The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2733-2017·Announced 2017-07-19

Oscor ATAR Disposable Extension Cables Recalled for Connector Separation Risk

Oscor, Inc. is recalling ATAR Disposable Extension Cables because they may separate from the connector during use, posing a risk to patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The Reusable Oscor ATAR extension cables could separate from the connector during use."

Plain-English summary

Oscor, Inc. is recalling ATAR Disposable Extension Cables, sold under brand names including ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. The recall involves 36,242 units distributed worldwide, including across the United States and various foreign countries.

The recall was initiated because the cables could separate from the connector during use. This defect may compromise the connection between the patient's electrode/lead and the diagnostic machine or external pacemaker.

Healthcare facilities and consumers should stop using the affected cables immediately. Users should check their inventory against the specific model codes and lot numbers listed in the official FDA recall notice Z-2733-2017 to identify affected units.

The recalled product

Product
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE…
Manufacturer
Oscor, Inc.
Category
Medical Device — Cardiac Monitoring / Pacemaker Accessories
Hazard
Affected units
36,242

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 (8)

  • ATAR D-MDTL DISPOSABLE (D2 02525)
  • ATAR D-R NP DISPOSABLE (B4-10113 B4-10274 B4-10363 B4-13018 C1-06686)
  • ATAR D-MDTR (D2-02210)
  • ATAR D-R T4P (D2-03946)
  • ATAR D-R X2 (C1-06767)
  • XI.D-MDT DISPOSABLE 30 CM (D2-02367 D2-02367 D2-02450 D2-02480 D2-02861)
  • XI.D-RL (D2-03578 D2-03715 OR-04766)
  • XI.D-R DISPOSABLE (D2-02481)

Distribution

Distributed in 39 states:

Part of a larger recall action

This product is one of 2 recalled by Oscor, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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