Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

198 recalls in our database name Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) as the manufacturing or recalling firm.

What the numbers show

Total: 198
Critical: 8
Severe: 126
Most recent: 2023-06-28

Of the 198 recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) we have scored against our rubric, 8 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 126 (64%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

126–150 of 198

SevereFDA (Devices)·Z-1486-2022·2022-08-17
Medtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1480-2022·2022-08-03
Medtronic Cobalt Implantable Cardioverter Defibrillators Recalled for Cathode Component Defect
Medtronic is recalling three Cobalt Implantable Cardioverter Defibrillators (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification. Affected patients should contact their physician.
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1267-2022·2022-06-22
Medtronic Cobalt ICD and CRT-D Telemetry Software Error Recall
Medtronic is recalling Cobalt and Crome ICDs and CRT-Ds due to a software telemetry error in the CareLink SmartSync Device Manager. The error may affect device communication and remote monitoring.
Product
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1268-2022·2022-06-22
Medtronic Crome and Cobalt Cardiac Defibrillators Recalled Due to Telemetry Error
Medtronic recalls 3,944 Crome and Cobalt ICDs and CRT-Ds due to a potential telemetry error affecting device communication with external monitors.
Product
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1206-2022·2022-06-08
Medtronic cardiac catheter system recalled due to sterility barrier defect
Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.
Product
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0782-2022·2022-03-23
LINQ II Insertable Cardiac Monitor Recalled for Moisture Ingress
Medtronic is recalling 8 LINQ II Insertable Cardiac Monitors due to moisture ingress susceptibility that may cause loss of functionality. Affected devices were distributed in the US (NJ, NY, PA, VA) and Italy.
Product
LINQ II Insertable Cardiac Monitor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0464-2022·2022-01-12
Medtronic Abre Venous Stent System recalled for reports of stent migration
Medtronic is recalling the Abre Venous Self-Expanding Stent System due to reports of stent migration. Approximately 21,653 devices were distributed nationwide and internationally.
Product
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0390-2022·2021-12-22
Medical Device ID Cards incorrectly printed with MR conditional system statement
Medtronic is recalling 187 Medical Device Identification Cards for Sprint Quattro Lead implants printed with an erroneous statement about MR conditional system status. Affected cards were distributed in the US, Canada, and Northern Mariana Islands.
Product
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0391-2022·2021-12-22
Astra XT DR Patient Identification Cards Printed with Incorrect MR Statement
Medtronic is recalling Astra XT DR patient identification cards that were printed with an incorrect statement about MR safety conditional status. The erroneous cards were distributed in the US, Canada, and Northern Mariana Islands.
Product
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0282-2022·2021-12-01
Medtronic Cardiac Device Software Affected by Data Processing Error
Medtronic is recalling software used in certain cardiac implant devices due to a data processing error that may fail to collect episode data. Approximately 18,715 devices are affected worldwide.
Product
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0173-2022·2021-11-03
Medtronic recalls C315-HIS Delivery Catheters due to functional defect
Medtronic is recalling 591 units of C315-HIS Delivery Catheters due to reports that a lead cannot pass through the catheter. The catheters were distributed internationally to multiple countries, and healthcare providers should contact Medtronic for guidance.
Product
C315-HIS Delivery Catheter
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2102-2021·2021-07-28
Medtronic Reveal LINQ implantable monitor may fail to detect heart rhythm events
Medtronic Reveal LINQ cardiac monitors may stop detecting dangerous heart rhythm abnormalities after partial electrical reset, potentially delaying clinical response.
Product
Medtronic Reveal LINQ LNQ11 / PA96000
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2076-2021·2021-07-21
Medtronic LINQ II Insertable Cardiac Monitor Detection Failure Recall
Medtronic is recalling the LINQ II Model LNQ22 Insertable Cardiac Monitor because it may fail to detect dangerous heart rhythms after a restart. The device was distributed worldwide.
Product
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1650-2021·2021-05-26
Medtronic Recalls Two Defective Implantable Cardioverter Defibrillators
Medtronic is recalling two Cobalt HF Quad MRI SureScan CRT-D devices due to a potential missing resistance spot weld.
Product
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1526-2021·2021-05-12
Medtronic Recalls CRT-P Pacemakers Due to Longevity Estimation Error
Medtronic is recalling specific implantable cardiac resynchronization therapy pacemakers because a longevity estimation error may occur in the early years of device life.
Product
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1523-2021·2021-05-12
Medtronic Recalls CRT-P Quad Models Due to Software Longevity Error
Medtronic is recalling 45,411 CRT-P Quad implantable devices worldwide because a software issue overestimates battery longevity for six months before replacement is due.
Product
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and card
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1522-2021·2021-05-12
Medtronic Recalls CareLink SmartSync Device Manager Due to Software Error
Medtronic is recalling 16,311 CareLink SmartSync Device Managers because a software issue may overestimate the remaining battery life of implanted cardiac devices.
Product
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1527-2021·2021-05-12
Medtronic Programmers Recalled for Longevity Estimation Error
Medtronic is recalling 2090 Carelink and 29901 Encore programmers due to a potential longevity estimation error in specific pacing configurations.
Product
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1528-2021·2021-05-12
Medtronic Recalls CareLink SmartSync Device Manager for Longevity Error
Medtronic is recalling 16,311 CareLink SmartSync Device Manager units worldwide due to a potential longevity estimation error when specific pacing vectors are programmed.
Product
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1525-2021·2021-05-12
Medtronic Recalls Implantable Pulse Generators Due to Longevity Estimation Error
Medtronic is recalling implantable pulse generators because a longevity estimation error may occur in early device life when specific pacing vectors are programmed.
Product
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureSca
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1306-2021·2021-04-07
Medtronic Recalls CRT-D Devices Due to Shortened Replacement Time
Medtronic is recalling specific CRT-D implantable cardioverter defibrillators because a small percentage may experience a shortened time before the device reaches end of service.
Product
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1305-2021·2021-04-07
Medtronic Recalls Implantable Cardioverter Defibrillators Due to Shortened Replacement Time
Medtronic is recalling specific Evera and Visia ICD models because a small percentage may experience a shortened Recommended Replacement Time to End of Service interval.
Product
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Impla
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0926-2021·2021-02-03
Medtronic COBALT HF QUAD CRT-D MRI SureScan Recall for Potential Loss of Function
Medtronic is recalling two specific COBALT HF QUAD CRT-D MRI SureScan devices due to a rare component failure mechanism that could cause loss of function.
Product
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0928-2021·2021-02-03
Medtronic Cobalt DR MRI SureScan Defibrillators Recalled for Potential Loss of Function
Medtronic is recalling two specific MRI SureScan defibrillators because a component failure could cause the device to lose function.
Product
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0927-2021·2021-02-03
Medtronic Cobalt HF CRT-D MRI SureScan Recall for Potential Loss of Function
Medtronic is recalling two specific Cobalt HF CRT-D MRI SureScan devices due to a rare failure mechanism that could cause loss of function.
Product
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Category
Medical Device
Distribution
3 states