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  4. Oscor Inc. Issues Nationwide Recall of ATAR Extension Cables
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Oscor Inc. Issues Nationwide Recall of ATAR Extension Cables

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:
Recall Reason Description
Cable separating from the connector at the proximal end
Company Name:
Oscor, Inc.
Brand Name:
Brand Name(s)
ATAR
Product Description:
Product Description
Extension cable

Company Announcement

INTENDED USE: The extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

DEVICE DESCRIPTION: The ATAR cable is an extension cable with connector(s) on both sides, designed to connect with various receptacles or cables/leads, depending on the instrument being used.

REASON FOR THE VOLUNTARY PRODUCT REMOVAL:

During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use.  This event resulted in cable malfunction, causing interruption of the pacing system.  Oscor received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries.  No deaths were reported; however the risk for possible injury is a concern if the cable separates during use. 
 
WARNING:

For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Continuous monitoring is required.

ATAR EXTENSION CABLE – REUSABLE MODELS:

ATAR-53912 & 53912A

ATAR-T2

ATAR-R X2

ATAR-MDTL
ATAR-MDT2S-V ATAR-R ATAR-MDT2 ATAR-T
ATAR A ATAR-RL ATAR-V2 ATAR-R T4P
ATAR-V ATAR MDT3 ATAR-R NP ATAR-MDTR
ATAR-AT ATAR-R1 XI.DR XI.DV
ATAR-MDTS ATAR-R D2P XI.DMDT XI.DA
ATAR-MDT ATAR-R T2P XI.DT  

 ATAR EXTENSION CABLE - DISPOSABLE MODELS:

ATAR-53912D

ATAR D-T2

ATAR D-R X2

ATAR D-MDTL
ATAR D-MDT2S-V ATAR D-R ATAR D-MDT2 ATAR D-T
ATAR D-A ATAR D-RL ATAR D-V2 ATAR D-R T4P
ATAR D-V ATAR DMDT3 ATAR D-R NP ATAR D-MDTR
ATAR-D-AT ATAR D-R1 XI. DR XI.V
ATAR D-MDTS ATAR D-R D2P XI.MDT XI.A
ATAR D-MDT ATAR D-R T2P XI.T  

Customer may contact Oscor’s Customer Service Group, Monday to Friday from 8:30AM to 6:00PM Eastern Time at 727-937-2511 or via email at atar@oscor.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to Expanded Recall

Company Contact Information

Consumers:
Oscor’s Customer Service Group
727-937-2511
atar@oscor.com
 
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