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

Recall Z-2507-2023 — Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium cas

U.S. FDA — Device Enforcement · United States · 2023-07-18 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2507-2023
Date of alert: 2023-07-18
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Abbott Medical
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05415067046383

Reported risk: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

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.

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