Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
FDA adverse event reports and recall history for pump, blood, cardiopulmonary bypass, non-roller type (product code KFM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 4,337
- Deaths
- 253
- Injuries
- 761
- Malfunctions
- 3,246
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-03-13Open, ClassifiedProcess control
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
- 2024-02-02Open, ClassifiedProcess control
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
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.
- 2024-02-02Open, ClassifiedProcess control
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
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.
- 2023-08-25Open, ClassifiedUnder Investigation by firm
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
- 2021-08-12TerminatedMaterial/Component Contamination
Spectrum Medical Quantum Standard heat exchanger
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
- 2019-10-30TerminatedProcess change control
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
- 2018-10-12TerminatedDevice Design
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.
- 2017-02-22TerminatedProcess control
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
- 2014-07-11TerminatedDevice Design
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
- 2014-07-11TerminatedDevice Design
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Monitor pump, blood, cardiopulmonary bypass, non-roller type automatically
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