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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recalls
198 recalls on record · February 28, 2018 to June 28, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 17, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model
Hazard: 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 defibrillators (CRT-Ds).
August 17, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model
Hazard: 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 defibrillators (CRT-Ds).
August 17, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Mode
Hazard: 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 defibrillators (CRT-Ds).
August 17, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Mod
Hazard: 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 defibrillators (CRT-Ds).
August 17, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, M
Hazard: 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 defibrillators (CRT-Ds).
August 17, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC
Hazard: 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 defibrillators (CRT-Ds).
August 3, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Hazard: Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
June 22, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3
Hazard: Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
June 22, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DV
Hazard: Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
June 8, 2022Medical DevicesFDA
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 implant procedure,
Hazard: The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
March 23, 2022Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls LINQ II Insertable Cardiac Monitor
Hazard: Devices may lose functionality due to susceptibility to moisture ingress.
January 12, 2022Medical DevicesFDA
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.
Hazard: There have been reports of stent migration.
December 22, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Hazard: 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."
December 22, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Hazard: 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."
December 1, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Cr
Hazard: The processing of collected episode data may fail due to a software error.
November 3, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls C315-HIS Delivery Catheter
Hazard: Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
July 28, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Reveal LINQ LNQ11 / PA96000
Hazard: Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.
July 21, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Hazard: Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
May 26, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Pro
Hazard: The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
May 12, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P
Hazard: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
May 12, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also prov
Hazard: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
May 12, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to b
Hazard: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
May 12, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devi
Hazard: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
May 12, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05
Hazard: There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
May 12, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Hazard: There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
April 7, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT C
Hazard: A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
April 7, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S D
Hazard: A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
February 3, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureSc
Hazard: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
February 3, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resyn
Hazard: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
February 3, 2021Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator
Hazard: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.