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 Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

For Immediate Release

September 27, 2018

Contact

Consumers

Oscor’s Customer Relations Group
TB@oscor.com
(727) 937-2511

Announcement

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.  The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins.  In the last six years, a total of four serious injuries were reported to Oscor which were attributed to a connector cap malfunction causing the lead connector to separate during use potentially leading to an interruption of the pacing system. No deaths were reported; however the risk for possible injury is a concern if the connectors separates during use. 

MODEL NUMBERS:

GTIN GUDID/Label
Model Number
TB Specification Description
Series French size Pin Curve Type
00836559009726 020004 TB 4F Unshrouded Straight
00836559009733 020005 TB 5F Unshrouded Straight
00836559009740 020006 TB 6F Unshrouded Straight
00836559009788 020010 TB 4F Unshrouded Atrial J
00836559009795 020011 TB 5F Unshrouded Atrial J
00836559009801 020012 TB 6F Unshrouded Atrial J
00836559009856 020017 TB 5F Unshrouded 60° Curve
00836559009863 020018 TB 6F Unshrouded 60° Curve
00836559009900 020022 TB 4F Unshrouded Right Heart
00836559009917 020023 TB 5F Unshrouded Right Heart
00836559009924 020024 TB 6F Unshrouded Right Heart
00836559009030 TBK04110USG TB 4F Unshrouded Straight
00836559009054 TBK05110USG TB 5F Unshrouded Straight
00836559009078 TBK06110USG TB 6F Unshrouded Straight
00885672007027 TBVK04110USG TB 4F Unshrouded 60° Curve
00885672007034 TBJK04110USG TB 4F Unshrouded Atrial J
00885672004378 TBRHK04110USG TB 4F Unshrouded Right Heart
00885672103682 TBRHK06110USG TB 6F Unshrouded Right Heart

Table 1: TB-Temporary Bipolar Pacing Lead with Un-shrouded Pins Affected Models.

Warning:

For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Continuous monitoring is required.
Customer may contact Oscor’s Customer Relations Group, Monday to Friday from 8:30AM to 5:30PM Eastern Time at 727-937-2511 or via email at TB@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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Product Photos

TB-Temporary Bipolar Pacing Lead with Un-shrouded Pins (Atrial J Model)

Page Last Updated: 09/27/2018
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