ROTAFLOW recallZ-0978-2024 · Maquet Medical Systems USA · initiated Jan 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Medical Systems USA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
FDA root cause category: Process control
What the company is doing
On January 8, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE Removal letters. Customers were instructed to remove all affected RF-32 pumps from use. If product is already in use, the firm advised to not discontinue therapy, but to monitor the patient closely for signs of infection. Customers should quarantine all affected product and return unopened/unexpired affected product to MCP/Getinge. Please contact MCP/Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to request a return authorization (RMA) number and shipping instructions. Distributors should forward the recall document to customers who received affected products. Information also posted on firm's website: https://www.getinge.com/us/products-and-solutions/cardiovascular-procedures/ ***Updated 3/21/24*** Firm expanded field action to include additional lots. Amended notifications were sent to affected US customers on March 20, 2024.
Recall details
- Recall number
- Z-0978-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 8, 2024
- Posted by the FDA
- Feb 2, 2024
- Recalling firm
- Maquet Medical Systems USA
- Quantity
- 1090 total
- Product code
- KFM
- FDA submissions
- K090515
- Distribution
- Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR, PA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.
Product description
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Code information (models, lots, serial numbers)
UDI-DI 4037691650326 Lots 3000283239 and 3000330438 ***Lots added 3/21/24*** 3000334430; 3000344495; 3000351245
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ROTAFLOW Centrifugal Pump, SOFTLINEMaquet Cardiopulmonary AG · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93852).
- Z-0977-2024 · Open, ClassifiedBEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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