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Medtronic Perfusion Systems

Medtronic Perfusion Systems Recalls

All product recalls associated with Medtronic Perfusion Systems.

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1441–1460 of 3680 recalls

Medtronic Bio-Console 560 Extracorporeal Blood Pumping Co... (Medtronic Perfusion Systems) – burn hazard (2021)

Fire/Burn Risk

An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.

High

FDAMar 3, 2021Nationwide• Medtronic Perfusion Systems

Consist of a distal connection mechanism (either standard... (Terumo Cardiovascular Systems Corporation) – there is a potential for the stainles... (2021)

There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

Moderate

FDAMar 2, 2021Nationwide• Terumo Cardiovascular Systems Corporation

Synapse PACS - Radiological Image Processing System - Pro... (Fujifilm Medical Systems U.S.A., Inc.) – the wrong patient information may be ... (2021)

1...71 727374 75...184

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The wrong patient information may be displayed in the viewer or PowerJacket.

High

FDAMar 2, 2021Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Ultrasonic pulsed doppler imaging system - Product Usage:... (Hitachi Medical Systems America Inc) – arietta 850 software version 4 (2021)

Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.

High

FDAMar 1, 2021Nationwide• Hitachi Medical Systems America Inc

Alaris Pump Module (Step-Har Medical) – Bezel Repair Risks (2021)

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

High

FDAFeb 26, 2021IA• STEP-HAR MEDICAL LLC

CARTO VIZIGO Guiding Sheath (Biosense Webster) – Hemostatic Valve Risk (2021)

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

Moderate

FDAFeb 26, 2021Nationwide• Biosense Webster, Inc.

Oyster Crackers (Old Cape Cod) – Foreign object risk (2021)

Product may contain hard plastic foreign object.

Class IIModerate

FDAFeb 26, 2021CA, CO, CT +10 more• Westminster Cracker Inc.

Midline Catheter Kit (Trinity Sterile) – Seal Contamination (2021)

Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility

High

FDAFeb 23, 2021Nationwide• Trinity Sterile, Inc.

Universal Robot UR5 Arm (Aesculap) – Robotic Arm Malfunction (2021)

Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.

Moderate

FDAFeb 19, 2021Nationwide• Aesculap Implant Systems LLC

TASWako Chip Cassette (Fujifilm) – Measurement Inaccuracy (2021)

Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

High

FDAFeb 18, 2021CA, LA, MN +3 more• Fujifilm Medical Systems U.S.A., Inc.

Vertical Drain Tube Device (Hollister) – Tube Holder Separation (2021)

The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might contribute to the potential risk of the tube/drain/catheter migration or loss.

Moderate

FDAFeb 11, 2021Nationwide• Hollister Incorporated

Triathlon Knee Prosthesis (Howmedica) – Component Sizing Problem (2021)

Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.

Moderate

FDAFeb 10, 2021AZ, GA, MA +10 more• Howmedica Osteonics Corp.

INFX-8000F System (Canon Medical) – X-Ray Field Shift (2021)

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

Moderate

FDAFeb 5, 2021Nationwide• Canon Medical System, USA, INC.

INFX-8000V System (Canon Medical) – X-Ray Field Shift (2021)

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

Moderate

FDAFeb 5, 2021Nationwide• Canon Medical System, USA, INC.

INFX-8000C System (Canon Medical) – X-Ray Field Shift (2021)

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

Moderate

FDAFeb 5, 2021Nationwide• Canon Medical System, USA, INC.