FDA Device recall Z-0165-2013

Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with…

FDA Device
Class II
terminated
Published 2012-11-07

On 2012-11-07 the FDA classified a Class II recall of Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with… by Oscor, citing 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 betwee….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0165-2013
Classification	Class II
Status	terminated
Initiated	2012-07-25
Published	2012-11-07
Last updated	2026-09-13 11:53 UTC
Company	Oscor
Distribution	AL, CA, FL, IL, IN, KY, NM, OH, OR, PA, TX

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

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.

Identifiers

code_info	Model Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056 Model Number TME64S, Lot #C1-07057 Model Numbe… 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

code_info

Model Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056 Model Number TME64S, Lot #C1-07057 Model Numbe…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

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All Oscor recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0165-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.