The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- 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
TB Temporary Bipolar Pacing Leads are used by a physician to stimulate or pace the heart to increase the heart rate. Temporary pacing leads are placed into a vein and advanced, so the tip touches the inside of the heart. This allows heart beat sensing and pacing as needed. The connector of the lead must be attached to an external pacing pulse generator for stimulation energy and timing.
Reason for Recall
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.
Who May be Affected
- Health care providers who use the TB Temporary Bipolar Pacing Leads in the treatment of patients with arrhythmias.
- Patients who use the TB Temporary Bipolar Pacing Leads.
What to Do
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.
Customers with questions may contact Oscor at 727-937-2511, Monday through Friday, from 8:30 AM Eastern Standard Time to 5:30 PM Eastern Standard Time, or email at TB@Oscor.com.
Date Recall Initiated
Oscor press release about this recall
How Do I Report a Problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
|GTIN||GUDID/Label Model Number||TB Specification Description|
|Series||French size||Pin||Curve Type|