Medtronic, Inc.
Medtronic, Inc. appears in FDA public data with 157 recalls — including 11 Class I (most serious) —, 244 510(k) clearances, 51 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1948-2026, Class II) was initiated on March 11, 2026. Its most recent 510(k) clearance was granted on June 24, 2026.
Summary
- Total Recalls
- 157 (11 Class I)
- 510(k) Clearances
- 244
- Inspections
- 51
- Compliance Actions
- 2
Known Names
mazor robotics, medtronic-xomed, medtronic cardiac rhythm and heart failure, nellcor puritan bennett, medtronic-usa, medtronic-sofamor-danek-usa, medtronic usa, medtronic ps medical, ev3 endovascular, medtronic-navigation
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1948-2026 | Class II | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for t | March 11, 2026 |
| Z-1098-2026 | Class II | Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9 | December 4, 2025 |
| Z-0726-2026 | Class II | Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrilla | October 29, 2025 |
| Z-2169-2025 | Class II | Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software compone | June 18, 2025 |
| Z-2168-2025 | Class II | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software compo | June 18, 2025 |
| Z-2128-2025 | Class II | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with t | June 17, 2025 |
| Z-2127-2025 | Class II | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the foll | June 17, 2025 |
| Z-1924-2025 | Class II | Azure S DR MRI SureScan, Product number W3DR01 | April 29, 2025 |
| Z-3152-2024 | Class II | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2 | July 11, 2024 |
| Z-2197-2024 | Class II | EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2202-2024 | Class II | MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2207-2024 | Class II | COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2198-2024 | Class II | EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2193-2024 | Class II | COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2192-2024 | Class II | Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2209-2024 | Class II | Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2204-2024 | Class II | MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2200-2024 | Class II | PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2208-2024 | Class II | COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2211-2024 | Class II | CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261866 | Concerto Versa Detachable Coil | June 24, 2026 |
| K253530 | Trexon Monofilament Synthetic Absorbable Suture | May 28, 2026 |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | April 23, 2026 |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | February 19, 2026 |
| K253998 | Clearview Intracoronary Shunts | January 20, 2026 |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | January 16, 2026 |
| K251831 | Bio-Medicus Life Support Catheter and Introducer | January 15, 2026 |
| K253511 | Concerto Versa Detachable Coil | January 14, 2026 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System | December 19, 2025 |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | June 20, 2025 |
| K250075 | Medtronic Stedi Extra Support Guidewire | June 13, 2025 |
| K250199 | VitalFlow Console | May 20, 2025 |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | March 27, 2025 |
| K243892 | Affera Integrated Mapping System | January 17, 2025 |
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Paci | January 17, 2025 |
| K243435 | Magnetic Localization Patch Kit (AFR-00021) | December 5, 2024 |
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | November 1, 2024 |
| K240880 | VitalFlow Set with Balance Biosurface | September 12, 2024 |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | August 7, 2024 |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with | June 12, 2024 |