Z-1866-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- April 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,880 components
Product Description
Blood Pump Rotor, Model Number: F40015481 Rev A
Reason for Recall
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Distribution Pattern
US Nationwide distribution.
Code Information
Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots.