Bio-Medicus™ 96600-125 (UDI 00763000060572)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000060572), received between Apr 20, 2022 and May 2, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K180456); they may or may not involve this specific model.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING THE USE OF THE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULA, AIR BUBBLES WERE OBSERVED WITHIN THE CANNULA AND WITHIN THE CANNULA WALL. THE PATIENT WAS PLACED ON VENTRICULAR ANEURYSM (VA) SUPPORT. THE DEVICE WAS REPLACED WITH ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948932 ↗
• InjuryMar 25, 2025Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT AFTER USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, A REMOVABLE SUTURE RING ON THE CANNULA CAME OFF AND WAS LEFT INSIDE THE PATIENT. THE COMPONENT WAS SURGICALLY REMOVED FROM THE PATIENT. NO REPLACEMENT OF THE DEVICE WAS NECESSARY TO COMPLETE THE CASE, AND DEVICE USE WAS CONTINUED.THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685451 ↗
• MalfunctionDec 12, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA AND KIT, IT WAS REPORTED THAT THE CUSTOMER COULD NOT THREAD ONTO THE CANNULA MAKING IT UNUSABLE. AN ADDITIONAL WIRE WAS TESTED ON THE DEVICE BUT IT WAS STILL UNUSABLE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913423 ↗
• MalfunctionDec 11, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT THE GUIDEWIRE WOULD NOT THREAD INTO THE CANNULA INTRODUCER. THE CUSTOMER TRIED IT FROM BOTH ENDS AND IT WOULD NOT PASS. THE DEVICE WAS REPLACED. THE CUSTOMER ALSO REPORTED THAT THE CASE WAS DELAYED BY A FEW MINUTES. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE OBTURATOR TIP WAS OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO KINK IN THE CANNULA. THE PUMP WAS LOCATED ON THE PATIENT'S RIGHT. THE CANNULA NEVER GOT CONNECTED TO THE CIRCUIT SINCE THE CANNULA COULD NOT BE SUCCESSFULLY INSERTED DUE TO THE FACT THAT THE OBTURATOR WOULD NOT ACCEPT A WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901204 ↗
• MalfunctionJul 22, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA KIT, IT WAS REPORTED THAT DURING THE FEMORAL VENOUS CANNULATION FOR A CARDIOPULMONARY BYPASS, THE CUSTOMER WAS UNABLE TO EXTRACT THE GUIDEWIRE FROM THE CANNULA EASILY. ONCE THE WIRE WAS REMOVED, IT WAS EXAMINED BY THE CUSTOMER AND IT WAS OBSERVED TO BE FRAYED/UNCOILED IN THE CENTER. THE WIRE WAS EXAMINED BY THE CUSTOMER AND IT WAS DEEMED TO BE COMPLETE. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792819 ↗
• MalfunctionJul 22, 2024Component Missing; Insufficient Device Problem Information; Component Missing; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT THE CUSTOMER OBSERVED A CANNULA WITH MULTI-STAGE DESIGN INSTEAD OF A BI-CAVAL DESIGN. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791471 ↗
• MalfunctionApr 8, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA KIT, IT WAS REPORTED THAT THE CONNECTOR WAS DIFFICULT TO GET TUBING ON. THE CUSTOMER STATED THAT THE CONNECTOR WAS DAMAGED/DEFORMED. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER STATED THAT THE PERFORMANCE OF THE CANNULA WAS NOT AFFECTED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19058858 ↗
• MalfunctionJan 10, 2024Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, THE CUSTOMER REPORTED THAT UPON OPENING THE STERILE PACKAGING OF THE DEVICE, IT WAS OBSERVED THAT THE CONNECTOR FOR THE DEVICE HAD A LARGE CRACK IN IT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482692 ↗
• MalfunctionJan 5, 2024Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA AND KIT, IT WAS REPORTED THAT THE CANNULA END 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 18451375 ↗
• MalfunctionNov 23, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL VI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT THERE WAS A PERFORATION IN THE DISTAL VENOUS CANNULA AFTER CIRCUIT CHANGE THAT WAS COVERED WITH A TAPE. CUSTOMER THOUGHT THIS MAY HAVE OCCURRED DURING CLAMPING FOR CIRCUIT EXCHANGE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18198241 ↗
• MalfunctionOct 3, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT ON OPENING THE PACKAGE THE CONNECTOR WAS BROKEN. IT WAS ALSO REPORTED THAT THE CANNULA WAS STORED OUT OF THE WHITE BOXES ON THEIR SHELF. THERE WAS NO DAMAGE TO THE STERILE BARRIER OR OTHER NOTABLE DAMAGE TO PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859508 ↗
• MalfunctionAug 18, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, THE CUSTOMER REPORTED THAT THE CANNULA WAS INSERTED INTO THE FEMORAL VEIN UNEVENTFULLY AND IT WAS USED FOR THE CARDIOPULMONARY BYPASS PART OF THE PROCEDURE WITHOUT ANY PATIENT OR PERFORMANCE ISSUES. UPON REMOVAL OF THE CANNULA AT THE END OF THE PROCEDURE THE SURGEON NOTED THAT THE CONNECTOR APPEARED TO BE DAMAGED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17570421 ↗
• MalfunctionMay 31, 2023Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED AN INSERTION ISSUE WITH THE 96600-125 25 FR BIO-MEDICUS CANNULA. THE FACILITY WAS USING THE CANNULA FOR THE FIRST TIME. WHEN THEY WENT TO PULL BACK THE INTRODUCER THE END PIECE CAME OFF. THIS PIECE IS RIGID WHITE PLASTIC AND SERVES AS A FINGER GRIP TO THE INTRODUCER. IT LOOKS LIKE A LEUR CAP, BUT IS NOT SUPPOSED TO COME OFF. THEY WERE ABLE TO PULL THE INTRODUCER BACK AND PROCEED WITH USING THE CANNULA. CANNULA PERFORMED WELL AND THIS DID NOT IMPACT THE PATIENT. NO PACKAGING DAMAGE WAS OBSERVED. THE CANNULA HAD JUST ARRIVED AT THE HOSPITAL THE DAY BEFORE THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029258 ↗
• MalfunctionApr 19, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME IT WAS REPORTED THAT THE DILATOR GOT STUCK IN THE BIO-MEDICUS ONE PIECE FEMORAL CANNULA. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768287 ↗
• InjuryMar 2, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE PIECE FEMORAL CANNULA, IT WAS REPORTED THAT THE WIRE WAS TOO TIGHT FOR THE CANNULA, AND THIS CAUSED THE WIRE TO BECOME STUCK INSIDE THE CANNULA BODY. IT WAS STATED THAT THERE WAS NO PATIENT INJURY BUT THE SURGEON NEEDED TO INTERVENE. THE CUSTOMER STATED THAT THEY HAD TO PULL THE ENTIRE CANNULA, DILATOR AND WIRE OUT OF THE PATIENT AND OPEN A NEW KIT AND START OVER. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT WHEN THE CUSTOMER TRIED TO THREAD THE CANNULA OVER THE WIRE AND THEY COULD NOT ADVANCE IT. THE CUSTOMER STATED THAT THEY HAD A PROBLEM REMOVING THE DILATOR ALSO. THE PROCEDURE WAS AN EMERGENT AORTIC DISSECTION REPAIR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT WHEN THE CANNULA, GUIDEWIRE AND DILATOR WERE REPLACED, THE SURGEON USED THE SAME INSERTION SITE AS THE INITIAL CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466799 ↗
• MalfunctionApr 20, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS BIO-MEDICUS NEXTGEN VENOUS CANNULA KIT, IT WAS REPORTED THAT AFTER INSERTION AND PLACEMENT OF THE CANNULA, THE SURGEON WAS UNABLE TO PULL OUT THE INTRODUCER WHILE THE CANNULA WAS IN THE PATIENT. THE CANNULA WAS THEN REMOVED. THE TEAM WAS UNABLE TO REMOVE THE INTRODUCER FROM THE CANNULA OUTSIDE OF THE PATIENT. IT WAS STUCK AT THE END OF THE CANNULA. A NEW CANNULA WAS OPENED AND PLACED WITHOUT INCIDENT AND THIS WAS USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14158311 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180456. One submission often covers many models, so check the product and lot details in each record.

• Z-2738-2026 · May 25, 2026 · Open, Classified
  Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula