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

Recall Z-0165-2013 — Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.

U.S. FDA — Device Enforcement · United States · 2012-07-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0165-2013
Date of alert: 2012-07-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Oscor, Inc.
Product category: device
Product type: Devices

Reported risk: Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.

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.

Recall Z-0165-2013 — Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.

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