Z-0978-2024Class II

BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an...

Name: Z-0978-2024 BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an...
Creator: Maquet Medical Systems USA
Published: 2024-01-08
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2024-01-08 / Open, Classified / root cause: manufacturing process

FDA source

Maquet Medical Systems USA began a recall of BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass... on 2024-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0978-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-08
Posted: 2024-02-02
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 1090 total
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 codes and lots: UDI-DI 4037691650326 Lots 3000283239 and 3000330438 ***Lots added 3/21/24*** 3000334430; 3000344495; 3000351245

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0978-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0977-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02
Z-0978-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02

Product code KFM

K090515Class IIRotaflow Centrifugal Pump with Softline Coating, Model Bo-RF-32 (USA)Maquet Cardiopulmonary, AG / cleared 2009-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)