Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
FDA Recall Z-0165-2013 · Posted 2012-10-29
Recalling FirmOscor, Inc.
Recall StatusTerminated
Product CodeLDF
Date Initiated2012-07-25
Date Terminated2013-12-17
Product Quantity1425
Reason for Recall
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.
Firm Action
Oscor sent a customer notification letter dated July 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to send the listed models and lots in their inventory back to the recalling firm for immediate replacement. They were also instructed to call Oscor Customer Service at 727-937-2511 to obtain a Return Goods Product (RGA) number.
For questions regarding this recall call 727-937-2511, ext. 133.
Root Cause
Process control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.