FDA Device Recall Z-0032-2018: St Jude Medical Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0032-2018.

Recall Res Number

Z-0032-2018

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

NIK

Event Number

78093

Product Quantity

10,453 units

Product Description Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

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 Software version 23.1.1

Related Establishments / Registrations

MicroPort CRM S.r.l. Registration: 1000165971 View Registration
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
MEDTRONIC, INC. Registration: 2182208 View Registration
Boston Scientific Corporation Registration: 2648729 View Registration
STERIS SPA Registration: 3002806603 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
St. Jude Medical, Cardiology Division, Inc. Registration: 3005334138 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
Abbott Medical Registration: 3006705815 View Registration
Sorin CRM SAS Registration: 3008159616 View Registration
Abbott Medical Registration: 3008494315 View Registration
Medtronic Distribution Center Registration: 3009380063 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
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
BIOTRONIK SE & CO. KG Registration: 9610139 View Registration
Medtronic Europe Sarl Registration: 9614453 View Registration
Boston Scientific Limited Registration: 9616693 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0032-2018

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer