Class I Recall of Oscor TB Temporary Bipolar Pacing Leads
Oscor is recalling the TB Temporary Bipolar Pacing Leads because the connector cap housing may slide and expose the internal wire. This can cause loss of connectivity or even breakage during movement of the cables and prevent the attached external pulse generator from pacing. Loss of pacing may cause slow heart rate and symptoms such as lightheadedness, passing out or death. The U.S. Food and Drug Administration (FDA) has classified this as a Class I Recall.
- Name: TB Temporary Bipolar Pacing Leads
- Model numbers
- Manufacturing Dates: December 21, 2011, to April 4, 2018
- Distribution Dates: December 21, 2011, to May 17, 2018
- Devices recalled in the U.S: 4,778 units
On September 26, 2018 and November 9, 2018, Oscor. issued via email and mail with a "PRODUCT RECALL - ACTION REQUIRED" and “EXPANDED NOTIFICATION” letters to all affected customers.
The letter instructed:
- Distributors: Examine inventory for affected devices, quarantine any affected devices, notify customers if the affected devices have been further distributed, retrieve those affected devices from customers, and return affected devices to Oscor.
- Hospitals: Examine inventory for affected devices, quarantine any affected devices, and return affected devices to Oscor.
Oscor is planning to replace the product as needed with a Helios Temporary Pacing Lead or refer customers to an alternate supplier of FDA and CE approved temporary leads. Please follow the link below for additional information.
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