Z-2342-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2024
- Initiation Date
- June 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units (all OUS)
Product Description
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, 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
Domestic: Nationwide Distribution. International: Canada.
Code Information
Model Number: 191014; UDI/DI: N/A (Canada only); Serial Number: 6K0S162351, 6K0S162352, 6K0S162353, 6K0S162354, 6K0S162355, 6K0S169113, 6K0S169114, 6K0S169115, 6K0S169116, 6K0S169117, 6K0S169118, 6K0S169119, 6K0S169120, 6K0S169121, 6K0S169122, 6K0S169123, 6K0S169124, 6K0S169125, 6K0S169126, 6K0S169127.