The Recall Desk
HighFDA (Devices)·Z-2340-2017·Announced 2017-07-19

Oscor ATAR Reusable Extension Cables Recalled for Connector Separation Risk

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

What this means for you

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 involves a medical device with a risk of harm (connector separation) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Oscor, Inc. is recalling ATAR Reusable Extension Cables, sold under brand names including ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. The recall involves 19,178 units distributed worldwide, including to the United States and various foreign countries.

The recall is being issued because the cables could separate from the connector during use. These cables are intended to connect an electrode or lead from a patient or another cable to a diagnostic machine or an external pacemaker.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2
Manufacturer
Oscor, Inc.
Affected units
19,178

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 (9)

  • 53912A - MDTS ATAR REUSABLE
  • ATAR-MDT2S-A DK BLUE 30CM REUSABLE (C1-08831 D2-04131)
  • ATAR-MDT2S-V WHITE 30CM REUSABLE (C1-08830 D2-04002)
  • ATAR-MDTL REUSABLE (D8-00005 D2-01352-00)
  • ATAR-MDTR REUSABLE (D2-02210 D2 02211 D2-02833 D2-02211)
  • ATAR-R REUSABLE (D2-03922 D2-01665)
  • ATAR-R T4P REUSABLE (D2-03560)
  • ATAR-V2 REUSABLE (D2-02787 D2-02647)
  • XI.R REUSABLE (D2-01665 D2-02141 D2-02423 D2-02449 D2-02486)

Distribution

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 →