Entity profile compiled from public source records
| Submission # | Device Name | Decision Date | Decision Description | Action |
|---|---|---|---|---|
| K190581 | Amplatzer Trevisio Intravascular Delivery System | 2019-04-05 | Substantially Equivalent | View Details |
| K192019 | Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 | 2019-11-08 | Substantially Equivalent | View Details |
| K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | 2019-09-17 | Substantially Equivalent | View Details |
| K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | 2020-06-26 | Substantially Equivalent | View Details |
| K201610 | IonicRF Generator | 2020-10-21 | Substantially Equivalent | View Details |
| K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled | 2020-11-25 | Substantially Equivalent | View Details |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | 2021-06-08 | Substantially Equivalent | View Details |
| K211989 | Aveir Introducer | 2021-07-27 | Substantially Equivalent | View Details |
| K212026 | Amplatzer Steerable Delivery Sheath | 2021-09-27 | Substantially Equivalent | View Details |
| K212738 | Amplatzer Talisman Delivery Sheath | 2021-09-27 | Substantially Equivalent | View Details |
| K213364 | EnSite X EP System | 2021-11-11 | Substantially Equivalent | View Details |
| K213494 | Aveir Retrieval Catheter | 2022-04-01 | Substantially Equivalent | View Details |
| K221397 | MitraClip G4 Steerable Guide Catheter | 2022-09-28 | Substantially Equivalent | View Details |
| K221750 | CPS AIM Universal II Slittable Inner Catheter | 2022-06-30 | Substantially Equivalent | View Details |
| K230283 | Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) | 2023-03-01 | Substantially Equivalent | View Details |
| K230411 | Dragonfly OpStar Imaging Catheter | 2023-04-14 | Substantially Equivalent | View Details |
| K230934 | ViewFlex Eco Reprocessed ICE Catheter | 2023-05-03 | Substantially Equivalent | View Details |
| K232458 | JETiHydrodynamic Thrombectomy System | 2023-12-19 | Substantially Equivalent | View Details |
| K232690 | Amulet Steerable Delivery Sheath | 2023-09-29 | Substantially Equivalent | View Details |
| K234118 | CentriMag Acute Circulatory Support System | 2024-01-26 | Substantially Equivalent | View Details |
| K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) | 2024-06-13 | Substantially Equivalent | View Details |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled | 2024-07-09 | Substantially Equivalent | View Details |
| K242016 | EnSite X EP System | 2024-08-09 | Substantially Equivalent | View Details |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | 2025-05-27 | Substantially Equivalent | View Details |
| K243224 | MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) | 2024-12-31 | Substantially Equivalent | View Details |
| K243493 | Agilis NxT Steerable Introducer Dual-Reach | 2024-12-13 | Substantially Equivalent | View Details |
| K243549 | JETi Hydrodynamic Thrombectomy System | 2025-04-04 | Substantially Equivalent | View Details |
| K250031 | Amplatzer Guidewire | 2025-10-03 | Substantially Equivalent | View Details |
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | 2025-07-25 | Substantially Equivalent | View Details |
| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | 2025-05-23 | Substantially Equivalent | View Details |
| K251231 | ViewFlex X ICE Catheter, Sensor Enabled | 2025-05-20 | Substantially Equivalent | View Details |
| K251234 | EnSite X EP System | 2025-07-30 | Substantially Equivalent | View Details |
| K252013 | EnSite X EP System | 2025-09-25 | Substantially Equivalent | View Details |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | 2025-12-17 | Substantially Equivalent | View Details |
| K252512 | Armada 14 NC PTA Catheter | 2026-02-13 | Substantially Equivalent | View Details |
| K253232 | Seguin Annuloplasty Ring | 2025-10-29 | Substantially Equivalent | View Details |
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | 2026-04-24 | Substantially Equivalent | View Details |
| K253516 | Assert-IQ (DM5100) | 2025-12-18 | Substantially Equivalent | View Details |
| K253907 | Disposable Radiofrequency Cannula | 2026-04-16 | Substantially Equivalent | View Details |
| K260212 | EnSite X EP System | 2026-04-20 | Substantially Equivalent | View Details |
| Recall # | Product Description | Initiation Date | Status | Action |
|---|---|---|---|---|
| Z-0458-2026 | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 Reason: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC). | 2025-10-06 | Open, Classified | View Details |
| Z-0459-2026 | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 Reason: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC). | 2025-10-06 | Open, Classified | View Details |
| Z-0491-2025 | Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. | 2024-10-17 | Open, Classified | View Details |
| Z-0492-2025 | Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. | 2024-10-17 | Open, Classified | View Details |
| Z-0493-2025 | Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. | 2024-10-17 | Open, Classified | View Details |
| Z-0494-2025 | Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. | 2024-10-17 | Open, Classified | View Details |
| Z-0495-2025 | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. | 2024-10-17 | Open, Classified | View Details |
| Z-0551-2025 | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server. Reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download. | 2024-10-01 | Open, Classified | View Details |
| Z-0552-2025 | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN Reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download. | 2024-10-01 | Open, Classified | View Details |
| Z-0664-2020 | Radiofrequency Grounding Pad, REF RF-DGP-L Reason: Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating. | 2019-10-14 | Terminated | View Details |
| Z-0720-2020 | CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion. Reason: A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas. | 2019-11-11 | Terminated | View Details |
| Z-0753-2025 | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads. Reason: Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing. | 2024-11-21 | Open, Classified | View Details |
| Z-0783-2020 | Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 Reason: Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices. | 2019-12-09 | Terminated | View Details |
| Z-0789-2020 | Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential. Reason: Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices. | 2019-12-09 | Terminated | View Details |
| Z-1557-2025 | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate. Reason: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. | 2025-02-15 | Open, Classified | View Details |
| Z-1695-2024 | Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO Reason: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. | 2024-02-05 | Open, Classified | View Details |
| Z-2265-2024 | Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY Reason: Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy. | 2024-05-16 | Open, Classified | View Details |
| Z-2358-2024 | Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
| Z-2359-2024 | Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
| Z-2360-2024 | Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
| Z-2361-2024 | Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
| Z-2362-2024 | Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
| Z-2363-2024 | Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
| Z-2364-2024 | Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
| Z-2365-2024 | Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
| Z-2366-2024 | Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
| Z-2367-2024 | Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | 2024-05-16 | Open, Classified | View Details |
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.