Medtronic Inc., Cardiac Rhythm and Heart Failure recalls
10 official recalls and safety alerts involving Medtronic Inc., Cardiac Rhythm and Heart Failure since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Medtronic Inc., Cardiac Rhythm and Heart Failure or the relevant agency.
- 2023-06-28
USMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators…
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)US Nationwide - Worldwide DistributionOfficial notice →- 2022-08-17
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b.…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy…
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide DistributionOfficial notice → - 2022-08-03
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)US Nationwide distribution in the states of Indiana and CA.Official notice → - 2022-06-22
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR:…
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL GA, HI, IA,…Official notice → - 2022-06-08
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the…
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2022-03-23
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls LINQ II Insertable Cardiac Monitor
Devices may lose functionality due to susceptibility to moisture ingress.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide distribution - US Nationwide distribution in the states of NJ, NY,…Official notice → - 2022-01-12
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
There have been reports of stent migration.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Distribution was nationwide. There was also military/government distribution.…Official notice → - 2021-12-22
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)US, Canada, Northern Mariana IslandsOfficial notice → - 2021-12-01
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following…
The processing of collected episode data may fail due to a software error.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide distribution - US Nationwide. There was military/government…Official notice → - 2021-11-03
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls C315-HIS Delivery Catheter
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Distributed internationally to Australia, Brunei Darussalam, China, Germany,…Official notice →