Medtronic Perfusion Systems
FDA Regulatory Profile
Medtronic Perfusion Systems appears in FDA public data with 110 recalls — including 15 Class I (most serious) —, 29 510(k) clearances, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2739-2026, Class II) was initiated on May 25, 2026. Its most recent 510(k) clearance was granted on July 10, 2024.
Summary
- Total Recalls
- 110 (15 Class I)
- 510(k) Clearances
- 29
- Inspections
- 11
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2739-2026 | Class II | Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascul | May 25, 2026 |
| Z-2738-2026 | Class II | Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass | May 25, 2026 |
| Z-2576-2026 | Class II | Octopus Evolution AS Tissue Stabilizer, Model TS2500 | May 12, 2026 |
| Z-2575-2026 | Class II | Octopus Evolution Tissue Stabilizer, Model TS2000 | May 12, 2026 |
| Z-2577-2026 | Class II | Octopus 4 Tissue Stabilizer, Model 29400 | May 12, 2026 |
| Z-2215-2026 | Class II | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmona | April 21, 2026 |
| Z-2216-2026 | Class II | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonar | April 21, 2026 |
| Z-2221-2026 | Class II | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary | April 21, 2026 |
| Z-2217-2026 | Class II | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary | April 21, 2026 |
| Z-2214-2026 | Class II | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmo | April 21, 2026 |
| Z-2222-2026 | Class II | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary | April 21, 2026 |
| Z-2220-2026 | Class II | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonar | April 21, 2026 |
| Z-2218-2026 | Class II | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary | April 21, 2026 |
| Z-2219-2026 | Class II | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary | April 21, 2026 |
| Z-1473-2026 | Class II | Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 | January 13, 2026 |
| Z-0539-2026 | Class II | Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 | October 20, 2025 |
| Z-0509-2026 | Class II | MC3 VitalFlow Console, REF 58100; Blood pump of ecmo | October 3, 2025 |
| Z-0487-2026 | Class II | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, | September 12, 2025 |
| Z-2481-2025 | Class I | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model | August 6, 2025 |
| Z-2482-2025 | Class I | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model | August 6, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity | July 10, 2024 |
| K181954 | autoLog IQ Autotransfusion System | August 22, 2018 |
| K123351 | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | March 19, 2013 |
| K101186 | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | September 3, 2010 |
| K090869 | MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113T | August 27, 2009 |
| K080824 | BIO-CONSOLE 560 | May 7, 2008 |
| K061254 | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 | June 23, 2006 |
| K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT | November 22, 2005 |
| K052372 | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C | September 22, 2005 |
| K051303 | BIO-CONSOLE, MODEL 560 | June 10, 2005 |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | May 24, 2005 |
| K050109 | TRILLIUM BIOPUMP PLUS, MODEL BPX80T | February 11, 2005 |
| K043179 | SELECT 3D ARTERIAL CANNULA | February 8, 2005 |
| K041830 | MAGELLAN RATIO DISPENSER KIT | September 29, 2004 |
| K040173 | PEDIATRIC AORTIC ROOT CANNULA | March 19, 2004 |
| K033468 | AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE | November 14, 2003 |
| K033416 | SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARME | November 5, 2003 |
| K033264 | MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES | October 31, 2003 |
| K031700 | MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 | August 29, 2003 |
| K031776 | MC2X MULTI-STAGE VENOUS CANNULA | July 25, 2003 |