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Open, Classified

Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. 2. Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. 3. Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan.

FDA Recall Z-1526-2021 · Posted None

Recall StatusOpen, Classified
Product CodeNIK
Date Initiated2021-04-06
Product Quantity333408 units

Reason for Recall

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

Firm Action

Beginning 06-APR-2021, Medtronic notified risk managers and practice managers of the field corrective action notification via 2- day UPS delivery of the consignee letter. Consignees were asked to confirm receipt of the notification. Medtronic Field Representatives have been instructed to begin installation of the software update. Outside the United States (OUS), communication began on 06- APR-2021 using locally approved methods. Confirmation will be obtained per locally approved methods. Medtronic Field Representatives will begin installation of the software update as it is available locally. A courtesy notification will be provided to physicians with affected devices.

Root Cause

Software design

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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