The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0165-2013·Announced 2012-11-07

Oscor Recalls Myocardial Heart Wires Due to Spacing Defect

Oscor, Inc. is recalling specific models of myocardial heart wires because the spacing between the anchoring zig-zag and the electrode is out of specification.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The defect involves a structural specification issue in a medical device used for cardiac pacing, which poses a risk of harm, but the source text does not report any injuries or illnesses.

Plain-English summary

Oscor, Inc. is recalling myocardial heart wires, including models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. These devices are intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.

The recall was initiated because the spacing between the anchoring zig-zag and the electrode is out of specification. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

The affected units were distributed worldwide, including in the United States (specifically OR, FL, AL, TX, NM, CA, PA, KY, IN, OH, and IL) and internationally to Canada, Russia, and New Zealand. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.

The recalled product

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
Oscor, Inc.
Category
Medical Device — Cardiac Pacing
Hazard
Affected units
1,425

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 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

Distribution

Distributed in 11 states:

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