Bio-MedicusRecalls & reported problems across all models
Medtronic, Inc. · 59 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Bio-Medicus model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 211
- Deaths reported
- 4
- Injuries reported
- 19
- Recalls
- 2
We found 59 models of Bio-Medicus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 211 adverse event reports in the FDA's MAUDE database, received between May 12, 2017 and Sep 28, 2026 — classified as 4 deaths, 19 injuries, 188 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (59 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Bio-Medicus recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2026Open, Classified
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Z-2739-2026 · Root cause: Packaging · Recall details · FDA record ↗
- Sep 13, 2021Open, Classified
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Z-0003-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported Bio-Medicus problems
Device problems
- Mechanical Problem59
- Crack50
- Material Deformation50
- Material Puncture/Hole28
- Fluid/Blood Leak22
- Device Markings/Labelling Problem11
- Material Separation10
- Misassembled During Installation10
Patient problems
- No Clinical Signs, Symptoms or Conditions182
- Hemorrhage/Blood Loss/Bleeding20
- No Consequences Or Impact To Patient4
- Aortic dissection2
- Exsanguination2
- Foreign Body In Patient2
- Insufficient Information2
- Vascular Dissection2
Bio-Medicus models
59 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bio-Medicus™ 96551Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall4 reports
- Bio-Medicus™ 96530-115Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
- Bio-Medicus™ 96553Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
- Bio-Medicus™ 96570-119Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 death17 reports
- Bio-Medicus™ 96600-125Catheter, cannula and tubing, vascular, cardiopulmonary bypass16 reports
- Bio-Medicus™ 96820-108Catheter, cannula and tubing, vascular, cardiopulmonary bypass13 reports
- Bio-Medicus™ 96670-123CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 death11 reports
- Bio-Medicus™ 96670-125Catheter, cannula and tubing, vascular, cardiopulmonary bypass11 reports
- Bio-Medicus™ 96570-117Catheter, cannula and tubing, vascular, cardiopulmonary bypass11 reports
- Bio-Medicus™ CB96570-017Catheter, cannula and tubing, vascular, cardiopulmonary bypass10 reports
- Bio-Medicus™ CB96570-015Catheter, cannula and tubing, vascular, cardiopulmonary bypass9 reports
- Bio-Medicus™ 96570-115Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 death7 reports
- BIO-MEDICUS® 96880-025Catheter, cannula and tubing, vascular, cardiopulmonary bypass7 reports
- Bio-Medicus™ 96570-015Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 death6 reports
- Bio-Medicus™ 96670-121Catheter, cannula and tubing, vascular, cardiopulmonary bypass5 reports
- Bio-Medicus™ 96820-108CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS4 reports
- Bio-Medicus™ 96570-021Catheter, cannula and tubing, vascular, cardiopulmonary bypass4 reports
- Bio-Medicus™ 96570-121Catheter, cannula and tubing, vascular, cardiopulmonary bypass4 reports
- Bio-Medicus™ 96570-115CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS3 reports
- Bio-Medicus™ 96820-110CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS3 reports
- Bio-Medicus™ 96570-019Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- Bio-Medicus™ 96600-123Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- Bio-Medicus™ 96670-123Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- Bio-Medicus™ 96600-121Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- Bio-Medicus™ 96600-125Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- Bio-Medicus™ CB96570-021Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- Bio-Medicus™ 96530-119Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- Bio-Medicus™ 96570-117Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- Bio-Medicus® 96670-021CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 reports
- Bio-Medicus® 96830-012CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 reports
- Bio-Medicus™ 96570-017Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- Bio-Medicus™ 96530-119Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- Bio-Medicus™ 96530-121Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- Bio-Medicus™ 96570-123Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- Bio-Medicus™ 96600-123Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- Bio-Medicus™ CB96345-023Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- Bio-Medicus™ CB96670-019Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- Bio-Medicus™ CB96670-021Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- BIO-MEDICUS® 96880-019Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- BIO-MEDICUS® 96530-015CATHETER, PERCUTANEOUS1 report
- BIO-MEDICUS® 96530-017CATHETER, PERCUTANEOUS1 report
- BIO-MEDICUS® 96600-021CATHETER, PERCUTANEOUS1 report
- Bio-Medicus® 96670-019CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Bio-Medicus® 96370-023CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Bio-Medicus® 96820-008CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Bio-Medicus® 96820-012CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Bio-Medicus® 96830-008CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Bio-Medicus™ 96820-112CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Bio-Medicus™ 96830-108CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Bio-Medicus™ CB96670-019CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- Bio-Medicus™ CB96570-015Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- Bio-Medicus™ CB96535-019Catheter, percutaneous1 report
- Bio-Medicus™ 96600-121Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- Bio-Medicus™ 96670-127Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- Bio-Medicus™ 96820-110Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- Bio-Medicus™ 96830-110Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- Bio-Medicus™ CB96570-019Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- Bio-Medicus™ CB96825-008Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- Bio-Medicus™ 96570-115Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
Recent Bio-Medicus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Deformation
Medtronic received information that prior to use of a Bio-Medicus cannula, it was reported that the tube tip was damaged. The device was replaced. There was no patient involvement, so no adverse effect occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913181 ↗MalfunctionSep 20, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834799 ↗MalfunctionSep 14, 2026Misassembled During Installation
Medtronic received information that prior to use of a Bio-Medicus NextGen femoral Bi-Caval venous cannula, it was reported that the outer packaging box for the product is labeled 96670-121, but the cannula inside bears the model number 96570-121. See attached photo. The device was replaced. There was no patient involvement, so no adverse effect occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755797 ↗MalfunctionAug 19, 2026Mechanical Problem; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50321400 ↗MalfunctionApr 24, 2026Contamination; Material Deformation
IT WAS REPORTED THAT, DURING CANNULA PLACEMENT, A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA AND KIT HAD A NOTCH/DEFECT OBSERVED IN THE CANNULA SUTURE RING, AND THERE WAS CONCERN THAT THE PRODUCT MIGHT BE CONTAMINATED OR HAVE OTHER ISSUES. THE CANNULA WAS IMMEDIATELY REPLACED DURING THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE NOTCH MEANS THE WHITE SUTURE RING, AND THE MAIN CONCERN IS THAT THE CANNULATION HAS BEEN CONTAMINATED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS NOT USED IN THE END, NOR WAS IT USED FOR THE SECOND TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24975906 ↗MalfunctionApr 22, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT, PRIOR TO USE, A BIO-MEDICUS NEXTGEN FEMORAL VENOUS CANNULA WAS FOUND WITH DAMAGED PACKAGING WHEN THE STERILE PEEL POUCH WAS OPEN AND THE STERILE BARRIER WAS COMPROMISED. WHEN THE BOX WAS OPENED, THE CANNULA FELL OUT OF THE OPENED STERILE PEEL POUCH ONTO THE GROUND. NO, OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED. THE CANNULA WAS NOT USED, AND IT WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24951163 ↗MalfunctionApr 20, 2026Mechanical Problem
IT WAS REPORTED THAT DURING USE OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, THE OBTURATOR/CANNULA STYLET COULD NOT BE WITHDRAWN. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24922453 ↗MalfunctionApr 16, 2026Material Deformation
IT WAS REPORTED THAT DURING USE OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, THE DEVICE WAS NOT PERFORMING EFFECTIVELY (POOR EFFECT). THE CANNULA WAS REMOVED, AND DEFORMATION OF THE CANNULA BODY WAS OBSERVED AFTER REMOVAL. THE CANNULA WAS REPLACED WITH ANOTHER PRODUCT. IT WAS UNKNOWN IF THERE WAS ANY COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24902634 ↗MalfunctionApr 9, 2026Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL/JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT IT BROKE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825327 ↗MalfunctionMar 25, 2026Mechanical Problem; Material Deformation
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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688891 ↗MalfunctionMar 25, 2026Mechanical Problem; Material Deformation
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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688834 ↗MalfunctionMar 25, 2026Mechanical Problem; Material Deformation
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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688737 ↗MalfunctionMar 18, 2026Mechanical Problem
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN INSERTION KIT, IT WAS REPORTED THAT WHILE PERFORMING ECMO (E XTRACORPOREAL MEMBRANE OXYGENATION) CANNULATION FOR THE PATIENT, CUSTOMER OPENED THE ARTERIOVENOUS CANNULA FOR PUNCTURE, AND FOUND THAT THE GUIDEWIRE COULD NOT PASS THROUGH. THE DILATOR TIP WAS ALSO NOT FULLY OPEN. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24628396 ↗MalfunctionMar 12, 2026Material Deformation
IT WAS REPORTED THAT A SOLID DILATOR WAS FOUND AMONG THE BIO-MEDICUS NEXTGEN INSERTION KIT PRIOR TO THE PROCEDURE, AND A DEFECTIVE PRODUCT WAS REPORTED. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577748 ↗MalfunctionMar 11, 2026Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT A CRACK WAS FOUND ON THE CONNECTOR UPON OPENING THE PACKAGE. THE DEVICE WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567614 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page