Z-1866-2024 Class II Ongoing
FDA device recall Z-1866-2024 was initiated by Fresenius Medical Care Holdings, Inc. on Apr 17, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 45,880 components.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- Apr 17, 2024
- 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1866-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026