Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Myocardial Heart Wires Intended for temporary atrial and ventricular pacing Recalled by Oscor, Inc. Due to Oscor, Inc. in Palm Harbor, FL is recalling...

Date: July 25, 2012
Company: Oscor, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Oscor, Inc. directly.

Affected Products

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

Quantity: 1425

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 11 states: AL, CA, FL, IL, IN, KY, NM, OH, OR, PA, TX

Affected (11 states)Not affected

About Oscor, Inc.

Oscor, Inc. has 35 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report