Z-0165-2013Class II

Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after...

Name: Z-0165-2013 Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after...
Creator: Oscor, Inc.
Published: 2012-07-25
License: https://open.fda.gov/license/

Oscor Inc. / initiated 2012-07-25 / Terminated / root cause: manufacturing process

FDA source

Oscor, Inc. began a recall of Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse... on 2012-07-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0165-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-25
Posted: 2012-10-29
Terminated: 2013-12-17
Recalling firm: Oscor Inc.
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.
Product code: LDF Electrode, Pacemaker, Temporary
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 1425
Distribution: 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
Product codes and lots: Model Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056 Model Number TME64S, Lot #C1-07057 Model Number TME64S, Lot #C1-07058 Model Number TME64S, Lot #C1-07111 Model Number TME64S, Lot #C1-07112 Model Number TME64S, Lot #C1-07113 Model Number TME64S, Lot #C1-07114 Model Number TME64S, Lot #C1-07122 Model Number TME64S, Lot #C1-07123 Model Number TME64S, Lot #C1-07124 Model Number TME64S, Lot #C1-07125 Model Number TME64C, Lot #C1-07143 Model Number TME64S, Lot #C1-07151 Model Number TME64S-3, Lot #C1-07156 Model Number TME65S, Lot #C1-07174

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0165-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0165-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-29

Product code LDF

K831695Class IITemp. Cardiac Pacing Wire Tme 60/61/65Oscor, Inc. / cleared 1983-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)