BioMedicus™ 96670-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169025974), received between Nov 24, 2022 and Dec 11, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, WHEN PLANNING ON INTRODUCING THE DEVICE, THE CUSTOMER REALIZED THAT THE GUIDEWIRE WOULD NOT PASS THROUGH THE INTRODUCER HOLE AS THERE SEEMED TO BE A BLOCK INSIDE THE INTRODUCER. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901047 ↗
• MalfunctionNov 27, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS CANNULA, IT WAS REPORTED THE CUSTOMER DETECTED A CRACK ON THE CONNECTOR WHEN OPENING THE STERILIZATION PACKAGING. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211930 ↗
• MalfunctionMay 30, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, THE CUSTOMER REPORTED A CRACK ON THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17018147 ↗
• MalfunctionApr 17, 2023Crack; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16750183 ↗
• MalfunctionMar 3, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME IT WAS NOTED THAT THIS BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA WAS CRACKED AT THE INTERFACE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. INFORMATION WAS REQUESTED REGARDING WHETHER THERE WAS A LEAK FROM THE CANNULA, IF THERE WAS BLOOD LOSS, THE AMOUNT OF BLOOD LOSS AND IF A TRANSFUSION WAS REQUIRED BUT THE INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477693 ↗
• MalfunctionMar 3, 2023Crack; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16476986 ↗
• MalfunctionJan 25, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA, IT WAS REPORTED THAT AFTER CONNECTING THE DEVICE THE CUSTOMER OBSERVED A LEAK AND THAT THERE WAS A FISSURE/CRACK ON THE CONNECTION. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240276 ↗
• MalfunctionNov 24, 2022Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS VENOUS CANNULA, IT WAS REPORTED THAT THERE WAS A CRACK ON THE ENTRANCE/OPENING OF THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15860331 ↗