Bio-Medicus™ 96670-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000060633), received between Aug 22, 2022 and Apr 24, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Crack” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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USE OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, THE OBTURATOR/CANNULA STYLET COULD NOT BE WITHDRAWN.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 ↗
• MalfunctionNov 22, 2023Crack; Air/Gas in Device; Crack; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT UPON CONNECTION TO THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT, CONTINUOUS AIR WAS NOTED IN THE CONNECTION WITH CLAMPS IN PLACE. THE CIRCUIT WAS DISCONNECTED AND RECONNECTED MULTIPLE TIMES WITHOUT RESOLUTION. 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 18190155 ↗
• MalfunctionNov 3, 2023

  PATIENT IN CATH LAB FOR VENO ARTERIAL ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) CANNULATION. VENOUS CANNULA OPENED AND PLACED BY SURGEON WITHOUT ISSUE. UPON CONNECTION TO ECMO CIRCUIT, CONTINUOUS AIR NOTED IN CONNECTION WITH CLAMPS IN PLACE. CIRCUIT DISCONNECTED AND RECONNECTED MULTIPLE TIMES WITHOUT RESOLUTION. FURTHER INSPECTION INTO CANNULA, CANNULA REMOVED, AND NEW CANNULA PLACED. PATIENT CONNECTED TO ECMO CIRCUIT WITH NO FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 18064320 ↗
• MalfunctionMar 28, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED WHEN THE CUSTOMER TRIED TO INSERT THE INTRODUCER AND THE HEMOSTASIS CAP ONTO THE CANNULA, THE CONNECTOR ON THE END CRACKED. THE CUSTOMER TRIED ANOTHER CANNULA WITH THE SAME MODEL AND SAME LOT NUMBER AND THE REPLACEMENT ALSO CRACKED. THE DEVICE WAS REPLACED WITH A THIRD CANNULA. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). NO OTHER DEVICES IN THE SAME SHIPPING/BOX CONTAINER WERE ALSO DAMAGED AS THEY ARE SOLD SEPARATELY. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. DAMAGE WAS NOTED AS CUSTOMER ATTEMPTED TO ASSEMBLE THEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HEMOSTASIS CAP WAS ATTACHED TO THE 3/8 CONNECTOR OF THE CANNULAE WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY. THE HUB WAS NOT PUSHED IN OR THROUGH THE HEMOSTASIS CAP, IT WAS AGAINST THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626185 ↗
• MalfunctionMar 28, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED WHEN THE CUSTOMER TRIED TO INSERT THE INTRODUCER AND THE HEMOSTASIS CAP ONTO THE CANNULA, THE CONNECTOR ON THE END CRACKED. THE CUSTOMER TRIED ANOTHER CANNULA WITH THE SAME MODEL AND SAME LOT NUMBER AND THE REPLACEMENT ALSO CRACKED. THE DEVICE WAS REPLACED WITH A THIRD CANNULA. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). NO OTHER DEVICES IN THE SAME SHIPPING/BOX CONTAINER WERE ALSO DAMAGED AS THEY ARE SOLD SEPARATELY. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. DAMAGE WAS NOTED AS CUSTOMER ATTEMPTED TO ASSEMBLE THEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HEMOSTASIS CAP WAS ATTACHED TO THE 3/8 CONNECTOR OF THE CANNULAE WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY. THE HUB WAS NOT PUSHED IN OR THROUGH THE HEMOSTASIS CAP, IT WAS AGAINST THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626158 ↗
• MalfunctionFeb 3, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, DILATION HAD BEEN COMPLETED, THE WIRE WAS STILL IN AND THE CUSTOMER ¿PLUGGED¿ THE BACK OF THE CANNULA AND THE CONNECTOR CRACKED. CANNULA WAS QUICKLY CHANGED OUT AND THE SAME THING HAPPENED TO THE SECOND CANNULA (#96670-125, LOT #224844175) - IT CRACKED AT THE CONNECTOR AT THE SAME POINT IN CANNULATION. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE.  IT WAS ALSO REPORTED THAT DURING THE TIME TAKEN TO CHANGE OUT BOTH CANNULAS, IT RESULTED IN DELAYED SUPPORT TO THE PATIENT. THE PATIENT SUFFERED A PERI-ARREST SITUATION IN THE CATH LAB WHICH IS WHAT MADE THE SITUATION URGENT. THE CRACKS WERE ON THE 3/8¿ CONNECTOR ON THE BACK OF THE CANNULA. THERE WERE TWO DIFFERENT PEOPLE MANAGING THE CANNULATION AND THE CONNECTOR CRACKED FOR BOTH PEOPLE IN THE SAME MANNER. THERE WERE NO SUTURES OR ANYTHING IN OR AROUND THE CONNECTOR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CRACK WAS THE LENGTH OF THE CONNECTOR. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16291072 ↗
• MalfunctionFeb 3, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, DILATION HAD BEEN COMPLETED, THE WIRE WAS STILL IN AND THE CUSTOMER ¿PLUGGED¿ THE BACK OF THE CANNULA AND THE CONNECTOR CRACKED. CANNULA WAS QUICKLY CHANGED OUT AND THE SAME THING HAPPENED TO THE SECOND CANNULA (#96670-125, LOT #224844175) . IT CRACKED AT THE CONNECTOR AT THE SAME POINT IN CANNULATION. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE.  IT WAS ALSO REPORTED THAT DURING THE TIME TAKEN TO CHANGE OUT BOTH CANNULAS, IT RESULTED IN DELAYED SUPPORT TO THE PATIENT. THE PATIENT SUFFERED A PERI-ARREST SITUATION IN THE CATH LAB WHICH IS WHAT MADE THE SITUATION URGENT. THE CRACKS WERE ON THE 3/8¿ CONNECTOR ON THE BACK OF THE CANNULA. THERE WERE TWO DIFFERENT PEOPLE MANAGING THE CANNULATION AND THE CONNECTOR CRACKED FOR BOTH PEOPLE IN THE SAME MANNER. THERE WERE NO SUTURES OR ANYTHING IN OR AROUND THE CONNECTOR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CRACK WAS THE LENGTH OF THE CONNECTOR. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16290984 ↗
• MalfunctionDec 13, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF TWO 23 FR BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULAE, IT WAS REPORTED THAT THE CUSTOMER NOTICED DAMAGE TO THE INNER PACKAGING OF THE CANNULAE WHICH CAUSED A BREAK IN STERILITY. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ONE OF THE CANNULAE WAS DAMAGED, IN ADDITION TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970194 ↗
• MalfunctionAug 22, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL VENOUS CANNULA, IT WAS REPORTED THAT THE TIP OF THE CANNULA WAS CRACKED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264155 ↗