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

Recall Z-1661-2014 — Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary trans

U.S. FDA — Device Enforcement · United States · 2014-04-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1661-2014
Date of alert: 2014-04-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Inc. Cardiac Rhythm Disease Management
Product category: device
Product type: Devices

Reported risk: Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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