Every recall we track for Medtronic Perfusion Systems — 109 in all — plus the complaints and injury reports the public filed about them.
Medtronic recalls EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR for potential pinhole leaks during cardiopulmonary bypass that could cause hypovolemia, vessel laceration, or organ dysfunction.
Medtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR due to pinhole leaks during cardiopulmonary bypass that may cause hypovolemia, vessel laceration, or organ dysfunction. Affected units have specific model and lot numbers.
Medtronic recalls EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR for possible pinhole leaks during cardiopulmonary bypass that could cause bleeding, vessel damage, or organ failure.
Medtronic Perfusion Systems recalls EOPA 3D Arterial Cannula DIL TIP 22FR used in cardiopulmonary bypass. Pinhole leaks may cause hypovolemia, vessel laceration, or organ dysfunction. Affected units have specific model and lot numbers.
Medtronic Perfusion Systems recalls EOPA 3D Arterial Cannula 22FR model 78322 due to potential pinhole leaks during cardiopulmonary bypass that could cause hypovolemia, vessel laceration, or organ dysfunction.
a ~150-character meta description summarising the recall.
Medtronic recalls pediatric arterial cannulas with trace blood material. Affected units may have loose foreign material causing minor issues during medical procedures.
Medtronic recalls adult cannula kits with trace blood material that may cause loose foreign objects. Affected units include specific product numbers and lot numbers. Contact Medtronic for details.
Medtronic recalls Octopus Evolution Tissue Stabilizer Model TS2000 with incorrect tube assembly. Affected units have serial numbers 0232992409, 0233010063, 0233010115. No remedy provided in recall notice.
Medtronic recalls Octopus 4 Tissue Stabilizer Model 29400 due to incorrect tubing assembly during manufacturing. Affected units have short tube on bottom and long tube on top. No remedy stated in recall notice.
Medtronic recalls Octopus Evolution AS Tissue Stabilizer Model TS2500 with incorrect tube assembly. Affected units have specific serial numbers and UDI-DI codes. Consumers should contact Medtronic for details.
Medtronic recalls specific lots of GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94115T) due to potential sterile barrier breach. Affected units include certain lot numbers and GTINs.
Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94913L) due to potential sterile barrier breach. Affected units may require replacement to prevent infection risks during medical procedures.
a ~150-character meta description summarising the recall.
a ~150-character meta description summarising the recall.
Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94665) due to potential sterile barrier breach. Affected units have specific lot numbers and GTINs.
Medtronic recalls specific lots of GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94113T) due to potential sterile barrier breach. Affected units may compromise infection control during medical procedures.
Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94215T) due to potential sterile barrier breach. Affected units may pose infection risks during medical procedures.
Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94913) due to potential sterile barrier breach. Affected units may pose infection risks during medical procedures.
Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94725) due to potential sterile barrier breach. Affected units may pose infection risks during medical procedures.
Medtronic recalls Octopus Nuvo Tissue Stabilizer (Product TSMICS1) due to incorrect tubing assembly during manufacturing, which may cause improper function.
Medtronic recalls HR-ACT cartridges with dry blood on labels. This could lead to contamination during use. Affected units include specific lot numbers. Contact Medtronic for details.
Medtronic recalls VitalFlow Consoles with E70 error code that causes temporary touch screen unresponsiveness. This issue may occur during normal operation but does not affect pump function.
Medtronic recalls Affinity NT Oxygenators with decreased CO2 gas transfer rates that may not meet performance requirements. Affected units have specific product numbers and serial codes.
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Model 12113 due to potential shape loss. Affected units sold in 2023-2024 with specific serial numbers. Contact for replacement or return.
Medtronic Perfusion Systems recalls specific left heart vent catheters due to potential shape loss. Affected models include SUCTION 12115 LV VENT 15FR with serial numbers starting 2023051189. Contact for remedy details.
Medtronic recalls specific left heart vent catheters that may not retain their shape. Affected models include SUCTION 12110 LV VENT 10FR with serial numbers from 2023120708 to 2024090768. Contact Medtronic for details.
Recalled Medtronic Perfusion Systems Aortic Root Cannula models 11012 AR, 11014 AR, and variants due to potential loose material causing stroke if not identified before use.
Medtronic Perfusion Systems recalls Select Series Angled Tip Arterial Cannula (Model 72422) due to incorrect labeling in seven lots. Affected units may have safety risks.
Medtronic Perfusion Systems recalls specific arterial cannula models due to incorrect labeling in seven lots. This may cause confusion in medical use. Affected units include model 77422 (22 Fr) and 77418 (18 Fr) with listed lot numbers.
Medtronic recalls specific pediatric arterial cannula models due to incorrect labeling in certain lots. Affected units may have labeling errors that could lead to improper use during medical procedures.
Medtronic recalls DLP Aortic Root Cannula with Flow-Guard (REF 11012) due to potential sterility breach from misaligned seal in specific lots. Affected units sold for cardiopulmonary bypass surgery.
Medtronic recalls DLP Single Stage Venous Cannulae (REF 67312) due to manufacturing error where straight tip models were incorrectly labeled as right angle metal tip. Affected units have specific lot numbers and GTIN.
Medtronic recalls TourniKwik Tourniquet Set (CFN 79012) due to incorrect component in some lots. Affected units have specific serial numbers. Consumers should contact Medtronic for details.
Medtronic recalls specific venous cannula models due to potential unsealed sterile packing. Affected units include various sizes and model numbers with specific lot numbers. Consumers should check their product details and contact Medtronic for guidance.
Medtronic recalls specific arterial cannulae models due to potential unsealed sterile packing. Affected items include various 20-24 Fr sizes with model numbers 77006-87222. Consumers should check model numbers and lot numbers listed to determine if their product is affected.
Medtronic recalls specific aortic root cannulae and cardioplegia needles due to potential unsealed sterile packing. Affected models include DLP 9 Ga (11 Fr) Aortic Root Cannula (Model 24009) and others. Consumers should check model numbers and lot dates.
Medtronic recalls Clearview Blower/Mister model 22120 (lot 2023040203, 2023040473) due to potential unsealed sterile packing. Affected units may pose infection risks during medical procedures.
Medtronic recalls two tourniquet kit models due to potential unsealed sterile packing. Affected units include specific model numbers and lot dates. Consumers should contact Medtronic for details.
Medtronic recalls DLP 1 mm Arteriotomy Cannula model 31001 with unsealed sterile packing. Affected units include specific lot numbers and GTINs sold in 2023. Consumers should check their product details and contact Medtronic for guidance.
Medtronic recalls specific suction tube models due to potential unsealed sterile packing. Affected units include model numbers 10050-10061 with certain lot numbers. Consumers should check their product details to determine if they are affected.
Medtronic recalls DLP Coronary Ostial Cannulae model 30050 with unsealed sterile packing. Affected units have specific lot numbers and GTINs. Consumers should check their product details.
Medtronic recalls specific cardioplegia adapter models due to potential unsealed sterile packing. Affected units include Model Numbers 25009, 25010, 14003, 14000, 11001G, 13002, and 10710 with specific lot numbers. Consumers should check their units and contact Medtronic for details.
Medtronic recalls specific left heart vent catheter models due to potential unsealed sterile packing. Affected units include various model numbers and lot numbers from 2023. Consumers should check their device details and contact Medtronic for guidance.
Medtronic recalls specific ClearView intracoronary shunt models due to potential unsealed sterile packing. Affected units include 1.00mm (model 31100), 1.25mm (31125), and 2.00mm (31200) shunts with certain lot numbers. Contact Medtronic for details.
Medtronic recalls specific vessel cannula models due to potential unsealed sterile packing. Affected units include Model 30004 and 30003 with certain lot numbers. Consumers should check their product details.
Medtronic recalls disposable pressure display sets with model numbers 61000 and 62000 due to potential unsealed sterile packing. Affected units include specific lot numbers and GTINs from March 2023.
Medtronic recalls DLP Vessel Cannula model REF 30000 with incorrect labeling for specific lots. This may cause confusion in medical use. Affected units include lot numbers 2023020890, 202305C126, and 2023020889.
Medtronic recalls Affinity Fusion Oxygenators with loose Temperature Monitoring Adapter that could cause complications during cardiopulmonary bypass procedures.
Medtronic recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance due to Temperature Monitoring Adapter coming loose during setup or disassembly, potentially causing safety issues.
Medtronic recalls Affinity Fusion Oxygenators with loose Temperature Monitoring Adapter that may cause complications during cardiopulmonary bypass procedures.
Medtronic recalls Affinity Fusion Oxygenator with Integrated Arterial Filter (BB841 model) due to Temperature Monitoring Adapter potentially coming loose during setup or disassembly, risking improper perfusion.
Medtronic recalls Affinity Fusion Oxygenators with loose Temperature Monitoring Adapters that may cause overheating during heart surgery. Affected units have specific serial numbers and lot codes.
Recall of Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance due to Temperature Monitoring Adapter coming loose during setup or disassembly, potentially causing complications during cardiopulmonary bypass procedures.
Medtronic recalls Cardioblate Gemini-S surgical ablation systems due to reported fractured jaw tips. Affected units include specific model numbers and lot numbers. Consumers should contact Medtronic for details.
Medtronic recalls 48 specific perfusion kit models due to endotoxin testing not being conducted, which may pose a risk of infection in medical use.
Medtronic recalls Cardioblate CryoFlex Surgical Ablation Consoles with potential intermittent electrical connectivity between console and probe. Affected units have specific serial numbers and models.
Medtronic recalls two pediatric insertion kit models due to label mix-up causing incorrect guidewire in kits. Affected kits have specific serial numbers and GTINs.
Medtronic recalls DLP Left Heart Vent Catheters with potential wire protrusion through the catheter tip. Affected units have specific model/lot numbers and were sold between September 2020 and May 2024.
Medtronic recalls DLP Left Heart Vent Catheters (model 12118) with potential wire protrusion through the catheter tip. Affected units have specific lot numbers and expiration dates from 09/30/2020 to 05/19/2024.
