HeartMate 3 Mobile Power Unit recall
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3…
Why was HeartMate 3 Mobile Power Unit recalled?
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers.
- Product
- HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3…
- Recalling firm
- Thoratec Corp.
- Quantity
- 13871
- Distribution
- US Nationwide distribution in the states of MN, PA, IL, NJ, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, CO, OH, DE, FL, NY, IN, GA, VA, DC, CT, OK, UT, KY, MD, OR, NM, ME, SC, IA, WA, LA, NV, AL, KS, MS, WV.
- Recall date
- January 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)