- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
Recall Reason DescriptionCable separating from the connector at the proximal end
- Company Name:
- Oscor, Inc.
- Brand Name:
- Product Description:
Product DescriptionExtension cable
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.
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 A||ATAR-RL||ATAR-V2||ATAR-R T4P|
|ATAR-V||ATAR MDT3||ATAR-R NP||ATAR-MDTR|
ATAR EXTENSION CABLE - DISPOSABLE MODELS:
ATAR D-R X2
|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 firstname.lastname@example.org.
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
- Oscor’s Customer Service Group