Medtronic
Medtronic appears in FDA public data with 157 recalls — including 11 Class I (most serious) —, 248 510(k) clearances, 51 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1948-2026, Class II) was initiated on Mar 11, 2026. Its most recent 510(k) clearance was granted on Sep 17, 2026.
Summary
- Total Recalls
- 157 (11 Class I)
- 510(k) Clearances
- 248
- 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 | Mar 11, 2026 |
| Z-1098-2026 | Class II | Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9 | Dec 4, 2025 |
| Z-0726-2026 | Class II | Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrilla | Oct 29, 2025 |
| Z-2169-2025 | Class II | Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software compone | Jun 18, 2025 |
| Z-2168-2025 | Class II | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software compo | Jun 18, 2025 |
| Z-2127-2025 | Class II | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the foll | Jun 17, 2025 |
| Z-2128-2025 | Class II | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with t | Jun 17, 2025 |
| Z-1924-2025 | Class II | Azure S DR MRI SureScan, Product number W3DR01 | Apr 29, 2025 |
| Z-3152-2024 | Class II | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2 | Jul 11, 2024 |
| Z-2190-2024 | Class II | COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
| Z-2191-2024 | Class II | COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
| Z-2201-2024 | Class II | MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
| Z-2196-2024 | Class II | EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
| Z-2212-2024 | Class II | Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT | Apr 16, 2024 |
| Z-2206-2024 | Class II | COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
| Z-2200-2024 | Class II | PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
| Z-2208-2024 | Class II | COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
| Z-2195-2024 | Class II | CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
| Z-2209-2024 | Class II | Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
| Z-2193-2024 | Class II | COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator | Apr 16, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K262913 | Protégé EverFlex Self-expanding Peripheral Stent System | Sep 17, 2026 |
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | Aug 28, 2026 |
| K262005 | Affera Integrated Mapping System | Aug 21, 2026 |
| K261335 | VitalFlow Set with Balance Biosurface | Jul 31, 2026 |
| K261866 | Concerto Versa Detachable Coil | Jun 24, 2026 |
| K253530 | Trexon Monofilament Synthetic Absorbable Suture | May 28, 2026 |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Apr 23, 2026 |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Feb 19, 2026 |
| K253998 | Clearview Intracoronary Shunts | Jan 20, 2026 |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | Jan 16, 2026 |
| K251831 | Bio-Medicus Life Support Catheter and Introducer | Jan 15, 2026 |
| K253511 | Concerto Versa Detachable Coil | Jan 14, 2026 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System | Dec 19, 2025 |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | Jun 20, 2025 |
| K250075 | Medtronic Stedi Extra Support Guidewire | Jun 13, 2025 |
| K250199 | VitalFlow Console | May 20, 2025 |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Mar 27, 2025 |
| K243892 | Affera Integrated Mapping System | Jan 17, 2025 |
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Paci | Jan 17, 2025 |
| K243435 | Magnetic Localization Patch Kit (AFR-00021) | Dec 5, 2024 |