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Oscor, Inc. recalls Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surge
Recalled November 7, 2012 · FDA recall Z-0165-2013 · Oscor
Hazard
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. · FDA Class II
Units
1425
Sold at
Worldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand
Description
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.
Product
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
Manufacturer(s)
Oscor, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →