Class IIOngoingZ-2218-2026
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Recalls in Minnesota
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 233 recalls
Class IIOngoingZ-2217-2026
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class IIOngoingZ-2216-2026
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class IIOngoingZ-2215-2026
Medtronic Perfusion Systems recalls Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class IIOngoingZ-2214-2026
Medtronic Perfusion Systems recalls Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR
Certain lots of product have the potential for a sterile barrier breach.
Medtronic Perfusion Sy…MNMay 27, 2026
Class IIOngoingZ-2201-2026
Medtronic Neuromodulation recalls Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest.…
Medtronic Neuromodulat…MNMay 20, 2026
Class IIOngoingZ-2049-2026
Boston Scientific Corporation recalls LUX-Dx II Plus
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only).…
Boston Scientific Corp…MNMay 13, 2026
Class IIOngoingZ-2048-2026
Boston Scientific Corporation recalls LUX-DX II
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only).…
Boston Scientific Corp…MNMay 13, 2026
Class IIOngoingZ-1948-2026
Medtronic, Inc. recalls Medtronic Sphere-9 Catheter
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization T…
Medtronic, Inc.MNMay 6, 2026
Class IOngoingZ-1771-2026
Boston Scientific Corporation recalls Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT…
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding t…
- With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator
- Nonconforming Material/Component
Boston Scientific Corp…MNMay 6, 2026
Class IOngoingZ-1770-2026
Boston Scientific Corporation recalls Boston Scientific Pacemaker
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding t…
Boston Scientific Corp…MNMay 6, 2026
Class IIOngoingZ-1926-2026
SurgiSmoke Solutions recalls Flamingo Funnel Large
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
SurgiSmoke SolutionsMNApr 29, 2026