FDA Device Recall Z-0033-2018: St Jude Medical Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0033-2018.

Recall Res Number

Z-0033-2018

Recalling Firm / Manufacturer

St Jude Medical Inc.

FEI Number

2017865

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-08-28

Date Posted

N/A

Date Terminated

2020-07-08

Product Code

OSR

Event Number

78093

Product Quantity

495,011 units (391,093 in US)

Product Description Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.

Reason for Recall New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Action Details Abbott sent an Important Cybersecurity Advisory dated August 28, 2017, to all affected customers to notify customers of the availability of the programmer software update and associated pacemaker firmware update. The notification material is in the form of a Physician Letter and Hospital Letter and will be delivered to physicians and hospitals with inventory in the US by overnight service. Customers with questions were instructed to contact their Abbott representative or the customers technical support hotline at 1-800-722-3774.

Distribution Pattern Worldwide Distribution

Code Information / Serial Numbers Model EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334

Related Establishments / Registrations

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BIOTRONIK, INC. Registration: 1028232 View Registration
ABBOTT MEDICAL Registration: 2017865 View Registration
PRO-TECH DESIGN & MFG., INC. Registration: 2032521 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
BENCHMARK ELECTRONICS, INC. Registration: 2133641 View Registration
TECHNICAL SERVICES FOR ELECTRONICS, INC. Registration: 2135338 View Registration
MEDTRONIC, INC. Registration: 2182208 View Registration
Greatbatch Medical Registration: 2183787 View Registration
Boston Scientific Corporation Registration: 2648729 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA Registration: 2649622 View Registration
STERIS SPA Registration: 3002806603 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
Plexus Manufacturing Sdn. Bhd. Registration: 3004593495 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3005210579 View Registration
Abbott Medical Registration: 3006705815 View Registration
Sorin CRM SAS Registration: 3008159616 View Registration
Technical Services for Electronics, Inc. Registration: 3008483389 View Registration
Abbott Medical Registration: 3008494315 View Registration
Medtronic Distribution Center Registration: 3009380063 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3010972758 View Registration
Plexus Electronica S. de R.L. de C.V.. Registration: 3011120183 View Registration
St. Jude Medical Coordination Center BVBA European Distribution Center Registration: 3012552532 View Registration
ABBOTT MEDICAL Registration: 3013288201 View Registration
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration
Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration
SUZHOU JENITEK MEDICAL CO., LTD. Registration: 3013921506 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
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MEDTRONIC IRELAND Registration: 9612164 View Registration
Medtronic Europe Sarl Registration: 9614453 View Registration
Boston Scientific Limited Registration: 9616693 View Registration

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Medical Device Recall: Z-0033-2018

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer