Safety

Company Announcement

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.

Oscor Inc. Issues Nationwide Recall of ATAR Extension Cables

For Immediate Release

July 6, 2017

Contact

Consumers

atar@oscor.com
727-937-2511

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 & 53912AATAR-T2ATAR-R X2ATAR-MDTL
ATAR-MDT2S-VATAR-RATAR-MDT2ATAR-T
ATAR AATAR-RLATAR-V2ATAR-R T4P
ATAR-VATAR MDT3ATAR-R NPATAR-MDTR
ATAR-ATATAR-R1XI.DRXI.DV
ATAR-MDTSATAR-R D2PXI.DMDTXI.DA
ATAR-MDTATAR-R T2PXI.DT 

 ATAR EXTENSION CABLE - DISPOSABLE MODELS:

ATAR-53912DATAR D-T2ATAR D-R X2ATAR D-MDTL
ATAR D-MDT2S-VATAR D-RATAR D-MDT2ATAR D-T
ATAR D-AATAR D-RLATAR D-V2ATAR D-R T4P
ATAR D-VATAR DMDT3ATAR D-R NPATAR D-MDTR
ATAR-D-ATATAR D-R1XI. DRXI.V
ATAR D-MDTSATAR D-R D2PXI.MDTXI.A
ATAR D-MDTATAR D-R T2PXI.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.

Healthcare professionals are encouraged to report any malfunction and/or adverse events related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
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.
 

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Page Last Updated: 07/06/2017
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