Myocardial Heart Wires Intended for temporary atrial and ventricular… — Class II medical device recall Z-0165-2013
Terminated recall by Oscor, Inc., reported 2012-11-07, distributed in AL, CA, FL, IL, IN, KY, NM, OH…. Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, T
| Recall number | Z-0165-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oscor, Inc., Palm Harbor, FL, United States |
| Recall initiated | 2012-07-25 |
| Classified | 2012-10-29 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2013-12-17 |
| Distributed | AL, CA, FL, IL, IN, KY, NM, OH, OR, PA, TX |
| Countries outside the US | CA, NZ, RU |
| Quantity | 1,425 |
| Reason classes | specification failure |
| Lot numbers | C1-07056, C1-07057, C1-07058, C1-07101, C1-07111, C1-07112, C1-07113, C1-07114, C1-07122, C1-07123, C1-07124, C1-07125, C1-07143, C1-07151, C1-07156, C1-07174 |
| Model numbers | TME60S, TME64C, TME64S, TME64S-3, TME65S |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0165-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.