Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1351-2020 — Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330

U.S. FDA — Device Enforcement · United States · 2020-01-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1351-2020
Date of alert
2020-01-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
St Jude Medical, Cardiac Rhythm Management Division
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05414734507646
Reported risk: Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.