Medtronic Inc.: 40 recalls on record

Recalls filed with 1 agency: FDA (40).

First recall on record: June 28, 2017. Most recent: May 6, 2026.

Risk classification: Class I: 2 · Class II: 38

Most recent recalls

DateAgencyProduct
May 6, 2026FDAMedtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac abla…Z-1948-2026
July 30, 2025FDAMedtronic CareLink SmartSync Device Manager, Model Number 24967A with the following softw…Z-2169-2025
July 30, 2025FDAMedtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following sof…Z-2168-2025
June 18, 2025FDAAzure S DR MRI SureScan, Product number W3DR01Z-1924-2025
September 25, 2024FDA2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Descripti…Z-3152-2024
July 3, 2024FDACOBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibri…Z-2190-2024
July 3, 2024FDACOBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibril…Z-2191-2024
July 3, 2024FDACOBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defi…Z-2193-2024
July 3, 2024FDAMIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter DefibrillatorZ-2202-2024
July 3, 2024FDAEVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter DefibrillatorZ-2197-2024
July 3, 2024FDACOBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defi…Z-2194-2024
July 3, 2024FDAProduct not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA …Z-2212-2024
July 3, 2024FDACROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibril…Z-2195-2024
July 3, 2024FDAPRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter DefibrillatorZ-2200-2024
July 3, 2024FDAEVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter DefibrillatorZ-2199-2024
July 3, 2024FDACobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter DefibrillatorZ-2209-2024
July 3, 2024FDACOBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter DefibrillatorZ-2210-2024
July 3, 2024FDACOBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter DefibrillatorZ-2206-2024
July 3, 2024FDACobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibril…Z-2192-2024
July 3, 2024FDACOBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter DefibrillatorZ-2207-2024
July 3, 2024FDAMIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter DefibrillatorZ-2204-2024
July 3, 2024FDAMIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter DefibrillatorZ-2205-2024
July 3, 2024FDAMIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter DefibrillatorZ-2201-2024
July 3, 2024FDACROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter DefibrillatorZ-2211-2024
July 3, 2024FDAPRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter DefibrillatorZ-2203-2024

Questions about this company

How many recalls does Medtronic Inc. have?
Recalert has 40 U.S. recalls on record for Medtronic Inc., published between June 28, 2017 and May 6, 2026.
What was the most recent Medtronic Inc. recall?
FDA recall Z-1948-2026, published May 6, 2026: Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Which agencies have handled Medtronic Inc. recalls?
Medtronic Inc. appears as the recalling firm in recalls from: FDA (40).

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