Entity profile compiled from public source records
| Registration # | Establishment Name | Location | Establishment Type(s) | Action |
|---|---|---|---|---|
| 1000121056 | Boston Scientific Corporation | Coventry, RI, US | Manufacture Medical Device | View Details |
| 1225687 | Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | QUINCY, MA, US | Manufacture Medical Device | View Details |
| 1828132 | BOSTON SCIENTIFIC CORPORATION | SPENCER, IN, US | Manufacture Medical Device | View Details |
| 2124215 | Boston Scientific Corporation | Saint Paul, MN, US | Complaint File Establishment per 21 CFR 820.198 | View Details |
| 2134265 | BOSTON SCIENTIFIC CORPORATION | Maple Grove, MN, US | Manufacture Medical Device | View Details |
| 2648729 | Boston Scientific Corporation | Dorado, PR, US | Manufacture Medical Device | View Details |
| 3002124543 | BIOCOMPATIBLES U.K. LIMITED, a BTG Company | Farnham, SURREY ENGLAND, GB | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3002968685 | AXONICS, INC. | Irvine, CA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3004135191 | LUMENIS, LTD. | YOKNEAM Northern, IL | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3004859241 | BOSTON SCIENTIFIC CORPORATION | La Aurora Heredia, CR | Manufacture Medical Device | View Details |
| 3005099803 | BOSTON SCIENTIFIC CORPORATION | Marlborough, MA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3005111382 | Boston Scientific International BV, European Dist. Ctr. | KERKRADE Limburg, NL | Manufacture Medical Device | View Details |
| 3005619880 | Boston Scientific Corporation | Roswell, GA, US | Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device | View Details |
| 3006630150 | Boston Scientific Neuromodulation Corporation | Valencia, CA, US | Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3007695959 | Boston Scientific Corporation | El Coyol Alajuela, CR | Manufacture Medical Device | View Details |
| 3009883402 | Boston Scientific Cardiac Diagnostic Technologies, Inc. | ROCHESTER, MN, US | Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3010705768 | Boston Scientific Corporation | Waltham, MA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3010878085 | VALENCIA TECHNOLOGIES CORPORATION | Valencia, CA, US | Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3012975098 | CORBIN CLINICAL RESOURCES, LLC | Cumberland, MD, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3013627970 | Cortex, Inc. | Santa Clara, CA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3014222368 | Boston Scientific Medical Device (Malaysia) SDN BHD | Taman Perindustrian Batu Kawan Pulau Pinang, MY | Manufacture Medical Device | View Details |
| 3015289131 | FARAPULSE, INC. | Menlo Park, CA, US | Manufacture Device in the United States for Export Only | View Details |
| 3015425075 | NALU MEDICAL | Carlsbad, CA, US | Manufacture Medical Device | View Details |
| 3015537318 | INTERA ONCOLOGY | Newton, MA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3019751610 | Boston Scientific Corporation | Mississauga Ontario, CA | Manufacture Medical Device | View Details |
| 3022298579 | Boston Scientific Cardiac Diagnostic Technologies, Inc. | Arden Hills, MN, US | Repack or Relabel Medical Device | View Details |
| 3022627847 | Silk Road Medical | Plymouth, MN, US | Manufacture Medical Device | View Details |
| 3025341484 | BOSTON SCIENTIFIC CORPORATION | Cartago, CR | Manufacture Medical Device | View Details |
| 3025434462 | Obsidio Inc | Maple Grove, MN, US | Manufacture Medical Device | View Details |
| 3027305778 | Cryterion Medical Inc. | Saint Laurent Quebec, CA | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3032507796 | BOSTON SCIENTIFIC CORPORATION | Johns Creek, GA, US | Manufacture Medical Device | View Details |
| 3038190598 | Chess Medical Inc. | Montreal Quebec, CA | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3041000776 | Bolt Medical Inc. | Carlsbad, CA, US | Manufacture Medical Device | View Details |
| 9616684 | Boston Scientific Limited | CORK Munster, IE | Manufacture Medical Device | View Details |
| 9616693 | Boston Scientific Limited | CLONMEL Tipperary, IE | Manufacture Medical Device | View Details |
| 9616793 | GALIL MEDICAL LTD. | YOKNEAM Northern, IL | Manufacture Medical Device | View Details |
| 9681260 | Boston Scientific Limited | GALWAY, IE | Manufacture Medical Device | View Details |
| Recall # | Product Description | Initiation Date | Status | Action |
|---|---|---|---|---|
| Z-0009-2024 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0010-2024 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0011-2024 | Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0012-2024 | Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0013-2024 | Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0014-2024 | Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0015-2024 | Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0016-2024 | Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0017-2024 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0018-2024 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0019-2024 | Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0020-2024 | Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0021-2024 | Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0022-2024 | Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0023-2024 | Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0024-2024 | Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter Reason: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | 2023-07-27 | Open, Classified | View Details |
| Z-0030-2009 | Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. Reason: Boston Scientific is initiating a voluntary recall of the Platinum Plus Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to | 2008-08-25 | Terminated | View Details |
| Z-0031-2009 | Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. Reason: Boston Scientific is initiating a voluntary recall of the Platinum Plus" Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to | 2008-08-25 | Terminated | View Details |
| Z-0040-06 | Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS Reason: Incorrect implantation may cause serious health complications | 2005-09-23 | Terminated | View Details |
| Z-0041-06 | Enteryx Injector Single Pack Order Number: M00572650-US and M00572630 -OUS Reason: Incorrect implantation may cause serious health complications | 2005-09-23 | Terminated | 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.