Blood Pump Rotor recall
Blood Pump Rotor, Model Number: F40015481 Rev A
Why was Blood Pump Rotor recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots.
- Product
- Blood Pump Rotor, Model Number: F40015481 Rev A
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 45,880 components
- Distribution
- US Nationwide distribution.
- Recall date
- May 29, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)