Thoratec LLC: Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US;

Hazard

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Details from the source

Reason for recall: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Algeria, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cyprus, C Quantity: 2424 Lot/code info: Lot Code: All units of the following models are impacted: Model 106017 UDI: 00813024011248 Model 106762 UDI: 00813024011286 Model 107801 UDI: 00813024011996 Note: Product bracketing is determined based on possible use of the controller. Since the backup battery has a 3 year life cycle, it can be replaced (per the IFU) and the controller will continue to be used.

UPC codes

00813024011248, 00813024011286, 00813024011996

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.