Data / Medical devices / United States / Medtronic Perfusion Systems
Medtronic Perfusion Systems: FDA-registered device maker in Minneapolis, MN, United States, 181 510(k) clearances
Medtronic Perfusion Systems is registered with the FDA (registration 2184009) in Minneapolis, MN, United States. It lists 46 device types. The FDA files 181 510(k) clearances under its listings, the newest dated January 20, 2026. 55 recall events name it as the recalling firm (4 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2184009
- FEI number
- 1000116158
- Address
- 7611 Northland Dr, Minneapolis, MN, United States, 55428
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 2, 1992
- Registered through
- 2027
- Brand names listed
- 540, 550M, 560, 68000 CARDIOBLATE, ABLATION PEN 4920501 W/PACING, ABLT PEN 49205YN W/PACE OUS18L, ACT, ACT EASY FILL DEVICE and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 181.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 20, 2026 | K253998 | Clearview Intracoronary Shunts | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 16, 2026 | K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | DTM | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| June 20, 2025 | K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 10, 2024 | K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | DTZ | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| June 12, 2024 | K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 19, 2024 | K240534 | Bio-Medicus Life Support Catheter and Introducer | QHW | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 23, 2024 | K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | DTR | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| December 7, 2023 | K231206 | DLP Silicone Coronary Artery Ostial Cannulae | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 30, 2023 | K232295 | LAA Exclusion System | PZX | Substantially Equivalent | Syntheon, LLC | accessdata.fda.gov |
| May 4, 2023 | K230960 | DLP Silicone Coronary Artery Ostial Cannulae | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 6, 2023 | K230640 | Affinity Fusion Oxygenator System | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 22, 2022 | K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 14, 2022 | K201057 | Bio-Medicus Life Support Catheter and Introducer | QHW | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| September 16, 2021 | K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | DTZ | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| July 15, 2021 | K201100 | Bio-Medicus Life Support Catheter and Introducer | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 3, 2020 | K200514 | Cardioblate Gemini-s Surgical Ablation Device | OCL | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| October 1, 2019 | K191526 | Cardioblate CryoFlex Surgical Ablation System | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| September 27, 2019 | K191444 | Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 27, 2019 | K191077 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 30, 2019 | K190623 | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | OCL | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 17, 2019 | K191029 | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 12, 2019 | K183490 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 3, 2019 | K190557 | Bio-Medicus Insertion Kit | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 18, 2019 | K183511 | Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 19, 2018 | K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | OCL | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| October 19, 2018 | K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 22, 2018 | K181954 | autoLog IQ Autotransfusion System | CAC | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| March 22, 2018 | K180456 | Bio-Medicus Adult Cannulae Kit | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 22, 2018 | K180453 | Bio-Medicus Adult Cannulae and Introducer | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 27, 2017 | K171979 | Tubing Pack | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 2, 2017 | K171308 | Tubing Pack | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 10, 2017 | K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) | DTR | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 1, 2017 | K162958 | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge | DTR | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| September 21, 2016 | K162016 | Affinity NT Oxygenator with Cortiva BioActive Surface | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 20, 2016 | K160091 | Temperature Probe, Affinity Temperature Probe | FLL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 15, 2016 | K153598 | Medtronic Bio-Medicus Adult Cannula Kit | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 16, 2015 | K151523 | Uncoated Tubing and Connector Components | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 27, 2015 | K151110 | Intersept Filtered Cardiotomy Reservoir | DTN | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 8, 2015 | K150530 | Level Sensor, Level Sensor Tape | DTW | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 9, 2015 | K150567 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 25, 2015 | K143083 | Bio-Medicus Pediatric Cannula and Introducers | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 20, 2015 | K150422 | EOPA 3D Arterial Cannula | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 18, 2014 | K142673 | Bio-Medicus Adult Cannulae and Introducer | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 24, 2014 | K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 23, 2014 | K133157 | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 | DRY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 15, 2014 | K141951 | DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 12, 2014 | K141233 | AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE | DTN | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 30, 2014 | K132730 | BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE | DPT | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 22, 2014 | K140192 | CARPENTIER BI-CAVAL FEMORAL CANNULA | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 20, 2014 | K140165 | MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 19, 2013 | K132712 | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 31, 2013 | K132995 | DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 28, 2013 | K132972 | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE | DTN | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 4, 2013 | K132645 | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | GAD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 10, 2013 | K131269 | DLP CORONARY OSTIAL PERFUSION CANNULAE | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 1, 2013 | K123733 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 27, 2013 | K123762 | DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 22, 2013 | K123314 | AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 9, 2013 | K122914 | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE | DTN | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 14, 2012 | K122827 | AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 7, 2012 | K122760 | AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE | DTM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 2, 2012 | K121878 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 19, 2012 | K122913 | AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| September 14, 2012 | K100645 | AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 25, 2012 | K120988 | DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 13, 2012 | K121767 | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 14, 2012 | K121451 | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 25, 2012 | K120612 | MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 2, 2011 | K113235 | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS | DXS | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 28, 2011 | K111658 | AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 23, 2011 | K111657 | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 16, 2010 | K100646 | AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE | DTM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 13, 2010 | K101271 | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | JOX | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 22, 2010 | K100631 | AFFIITY CP CENTRIFUGAL BLOOD PUMP | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 10, 2010 | K100274 | MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 22, 2010 | K093535 | AUTOLOG AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 26, 2010 | K093203 | CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 | GEI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 17, 2010 | K093650 | BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM | DTY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 7, 2008 | K080824 | BIO-CONSOLE 560 | DWA | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| May 5, 2008 | K080509 | CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 3, 2007 | K071253 | AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 | DTM | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| June 18, 2007 | K070288 | CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 | OCL | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| May 22, 2007 | K070286 | BIO-CONSOLE, MODEL 560 | DWA | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| April 24, 2007 | K070311 | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 | GEI | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 21, 2007 | K070213 | PERFORMER CBP SYSTEM | DTQ | Substantially Equivalent | Rand S.R.L. | accessdata.fda.gov |
| June 23, 2006 | K061254 | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| March 15, 2006 | K052555 | MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB | DTQ | Substantially Equivalent | Rand S.R.L. | accessdata.fda.gov |
| February 28, 2006 | K060400 | CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT | GEI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 22, 2005 | K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| September 22, 2005 | K052372 | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| February 8, 2005 | K043179 | SELECT 3D ARTERIAL CANNULA | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| December 21, 2004 | K043291 | CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 | GEI | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| October 18, 2004 | K042206 | PURPLE/BLACK HEPARIN ASSAY CONTROL | GGN | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| October 18, 2004 | K042175 | HEPARINASE HR ACT CONTROL, MODEL 550-12 | GGN | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 19, 2004 | K040173 | PEDIATRIC AORTIC ROOT CANNULA | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| October 31, 2003 | K033264 | MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| May 13, 2003 | K031037 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| April 11, 2003 | K030696 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| January 8, 2003 | K024069 | ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 | DWF | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| January 8, 2003 | K022272 | MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) | DWF | Substantially Equivalent | Medtronic Cardiac Surgical Products | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 24, 2026 | 99320 | Class II | Ongoing | EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422 | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. | accessdata.fda.gov |
| May 25, 2026 | 99199 | Class II | Ongoing | Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | accessdata.fda.gov |
| May 12, 2026 | 98966 | Class II | Ongoing | Octopus Evolution Tissue Stabilizer, Model TS2000 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | accessdata.fda.gov |
| April 21, 2026 | 98786 | Class II | Ongoing | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | accessdata.fda.gov |
| January 13, 2026 | 98354 | Class II | Ongoing | Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 | During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | accessdata.fda.gov |
| October 20, 2025 | 97912 | Class II | Ongoing | Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 | Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. | accessdata.fda.gov |
| October 3, 2025 | 97806 | Class II | Ongoing | MC3 VitalFlow Console, REF 58100; Blood pump of ecmo | As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function th | accessdata.fda.gov |
| September 12, 2025 | 97702 | Class II | Ongoing | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. | accessdata.fda.gov |
| August 6, 2025 | 97295 | Class I | Ongoing | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 | The catheters may not retain their shape. | accessdata.fda.gov |
| February 5, 2025 | 96259 | Class I | Ongoing | Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 1 | Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible). | accessdata.fda.gov |
| December 12, 2024 | 96015 | Class II | Ongoing | DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr) | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | accessdata.fda.gov |
| October 3, 2024 | 95507 | Class II | Ongoing | Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery | There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal | accessdata.fda.gov |
| July 9, 2024 | 95152 | Class II | Ongoing | Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 | During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312). | accessdata.fda.gov |
| May 16, 2024 | 94856 | Class II | Ongoing | TourniKwik Tourniquet Set (CFN 79012) | Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. | accessdata.fda.gov |
| March 19, 2024 | 94274 | Class II | Ongoing | Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP Curved Metal Tip Arterial Cannula | Potential for unsealed sterile packing. | accessdata.fda.gov |
| February 7, 2024 | 94068 | Class II | Ongoing | Medtronic DLP Vessel Cannula, Model Number REF 30000 | Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above. | accessdata.fda.gov |
| December 12, 2022 | 91343 | Class II | Ongoing | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass. | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit. | accessdata.fda.gov |
| April 20, 2022 | 90089 | Class II | Ongoing | Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 ca | Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. | accessdata.fda.gov |
| October 12, 2021 | 88932 | Class II | Ongoing | Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PAC | Product is labeled as non-pyrogenic but endotoxin testing was not performed. | accessdata.fda.gov |
| September 27, 2021 | 88845 | Class II | Ongoing | Cardioblate CryoFlex Surgical Ablation Console | There is potential for intermittent electrical connectivity between the console and probe. | accessdata.fda.gov |
| September 13, 2021 | 88685 | Class II | Ongoing | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. | There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers. | accessdata.fda.gov |
| August 24, 2021 | 88549 | Class II | Ongoing | DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only | Potential for a wire protrusion through the left heart vent catheter tip | accessdata.fda.gov |
| April 29, 2021 | 87915 | Class II | Terminated | Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx. | Specific lots may have been manufactured with insufficient or incomplete welds. | accessdata.fda.gov |
| March 3, 2021 | 87490 | Class I | Ongoing | Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures. | An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use. | accessdata.fda.gov |
| February 4, 2021 | 87271 | Class I | Terminated | Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosu | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. | accessdata.fda.gov |
| November 14, 2019 | 84410 | Class II | Terminated | Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 | Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port. | accessdata.fda.gov |
| November 27, 2018 | 81702 | Class II | Ongoing | RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir. | Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit. | accessdata.fda.gov |
| August 8, 2018 | 85821 | Class II | Terminated | Extra corporeal circuit with bio-active surface. | Affected products failed a sterilization test. | accessdata.fda.gov |
| February 8, 2018 | 79235 | Class II | Terminated | BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when h | Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course of action is to request BIO CAL users to discontinue use and dispose of BIO CAL devices. | accessdata.fda.gov |
| January 16, 2018 | 79058 | Class II | Terminated | Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal | Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products. | accessdata.fda.gov |
| January 3, 2018 | 78977 | Class II | Terminated | Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures. | Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve. | accessdata.fda.gov |
| June 22, 2017 | 77641 | Class II | Terminated | DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery | Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. | accessdata.fda.gov |
| February 4, 2016 | 73261 | Class III | Terminated | Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion T | Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Med | accessdata.fda.gov |
| October 28, 2015 | 72550 | Class II | Terminated | Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup effi | This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag. | accessdata.fda.gov |
| August 18, 2015 | 72025 | Class II | Terminated | MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status. | Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs. | accessdata.fda.gov |
| July 24, 2015 | 71897 | Class II | Terminated | Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration. | EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. | accessdata.fda.gov |
| June 12, 2015 | 71517 | Class II | Terminated | Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethan | Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing. | accessdata.fda.gov |
| October 31, 2014 | 69746 | Class II | Terminated | The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and a | Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. UPDATED: Recall was updated to incorporate three additiona | accessdata.fda.gov |
| September 9, 2011 | 59948 | Not yet classified | Terminated | Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg to +300 mmHg and +/-10 mmHg from +301 to | The DFU for the Medtronic Pressure Display Box, model 66000, states that, for display readings of -100 to +300 mmHg there will be an accuracy of +/-5 mmHg, and for display readings of +301 to +500 mmHg there will be an accuracy of +/-10 mmHg. Through reports from customers, Medtronic has become aware that the Pressure Display Box may not always accurately di | accessdata.fda.gov |
| September 13, 2010 | 56902 | Not yet classified | Terminated | Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabilization system consisting of a rigid shaft, detachable tissue stabilizer headlink and a flexible ar | Medtronic has received reports regarding the Octopus Nuvo Tissue Stabilizer stating that during use, the collet (a component of the device that stabilizes the head link) fractured, thereby causing immediate separation of the head link from the shaft of the device. The resulting potential hazards are that fragments of the collet could fall into the patient's | accessdata.fda.gov |
| April 21, 2010 | 55749 | Not yet classified | Terminated | Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: Medtronic Bio-C | The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy b | accessdata.fda.gov |
| April 2, 2010 | 55900 | Not yet classified | Terminated | Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally connected to needles via | Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has become separated from the needle assembly. These instances of separation have occurred when pulling the clip through prosthetic material, or when grasping and releasing the clip using robotic instrumentation. While this issue does not impact performance of | accessdata.fda.gov |
| March 23, 2009 | 51785 | Not yet classified | Terminated | Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. | Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds t | accessdata.fda.gov |
| February 25, 2009 | 51952 | Not yet classified | Terminated | Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits | Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the as | accessdata.fda.gov |
| September 29, 2008 | 50173 | Not yet classified | Terminated | DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers. | Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients. | accessdata.fda.gov |
| May 9, 2008 | 48100 | Not yet classified | Terminated | Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Resistant Fiber. Single Use gas exchange device for Cardiopulmonary Bypass. Catalog Number: 71166 | Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSC | accessdata.fda.gov |
| May 7, 2008 | 48101 | Not yet classified | Terminated | Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215, 95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R41, 0R35R13, 0Y95R22, 17 | Medtronic is advising that certain Trillium-coated Medtronic cardiopulmonary bypass (CBP) products (e.g., oxygenators, reservoirs, pumps and tubing packs) were manufactured with heparin batches contaminated with oversulfated chondroitin sulfate (OSCS). Based upon currently available information, Medtronic has determined that Medtronic Trillium-coated product | accessdata.fda.gov |
| October 1, 2007 | 45485 | Not yet classified | Terminated | Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604. | Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin | accessdata.fda.gov |
| August 1, 2007 | 38485 | Not yet classified | Terminated | Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included wit | Medtronic Custom Tubing Packs might have open header bag seals. | accessdata.fda.gov |
| June 4, 2007 | 38154 | Not yet classified | Terminated | Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S | Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB)) | accessdata.fda.gov |
| April 18, 2007 | 37273 | Not yet classified | Terminated | Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN | Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic''s internal specifications while the product is labeled as nonpyrogenic. | accessdata.fda.gov |
| January 2, 2007 | 37079 | Not yet classified | Terminated | Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled | One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow. | accessdata.fda.gov |
| September 13, 2006 | 36333 | Not yet classified | Terminated | Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulm | An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications. | accessdata.fda.gov |
| March 25, 2005 | 31477 | Not yet classified | Terminated | Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, St | Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly & had been sterilized, the ruptured seal breaches the sterility barrier for the package. | accessdata.fda.gov |
| March 25, 2004 | 28638 | Not yet classified | Terminated | Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R | An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product. | accessdata.fda.gov |
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Updated July 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.