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# Oscor Expands TB Pacing Lead Recall
- URL: https://www.fdaweb.com/oscor-expands-tb-pacing-lead-recall/
- Published: 2018-11-15T12:00:00.000Z
- Updated: 2026-09-15T00:45:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142831

FDA says Oscor has expanded its 9/29 recall for certain lots of TB Unshrouded Bipolar Pacing Leads to include expired inventory for devices distributed between 12/21/11 and 5/17/18\. A company recall [notice](https://www.fda.gov/Safety/Recalls/ucm625786.htm?utm%5Fcampaign=FDA%20MedWatch%20Recall%20Notice%20-%20TB%20Unshrouded%20Bipolar%20Pacing&utm%5Fmedium=email&utm%5Fsource=Eloqua) posted by FDA says the expansion is to ensure proper disposition of expired units.

The leads are used transvenously for temporary pacing and sensing of the heart in conjunction with a compatible external pulse generator.

Oscor says that during the use of some leads, the connector cap housing may slide and potentially expose the connection wire. In some instances, the wire could be more susceptible to loss of connectivity or breakage during movement of the cables, causing interruption of the pacing system. In the last six years, the company says, four serious injuries were reported to Oscor that were attributed to a connector cap malfunction causing the lead connector to separate during use, potentially leading to an interruption of the pacing system. While no deaths were reported, the company says, the risk for serious injury and/or death is a concern if the connector separates during use.