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

Recall Z-2364-2024 — Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only

U.S. FDA — Device Enforcement · United States · 2024-05-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2364-2024
Date of alert
2024-05-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Medical
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05415067046383
Reported risk: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
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.