BioMedicus™ 96570-117Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169025776), received between Mar 23, 2022 and Jun 30, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE WHEN PLACING THE CANNULA, THE CUSTOMER REPORTED THE TIP OF THE BIO-MEDICUS CANNULA WAS BROKEN. THE DEVICE WAS REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236952 ↗
• MalfunctionMay 31, 2023Material Puncture/Hole; Component Missing; Material Puncture/Hole; Component Missing

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED THAT THE CANNULA WAS CRACKED AND MISSING ITS CAP AT THE END TOP OF THE CANNULA. THE CRACK WAS AT THE HUB, ABOUT 1/2 AN INCH IN SIZE. THE PRODUCT WAS REPLACED WITH ANOTHER MEDTRONIC CANNULA TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. ADDITIONAL INFORMATION: THE SITE NOTICED THE CAP WAS MISSING BEFORE OPENING THE POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029242 ↗
• MalfunctionSep 23, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN CANNULA, IT WAS REPORTED THAT THE CAP OF THE CANNULA CRACKED WHEN THE CUSTOMER WAS CONNECTING IT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 15475144 ↗
• MalfunctionApr 26, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN CANNULA, IT WAS REPORTED A THAT THE CONNECTOR WAS CRACKED. THE DEVICE USE WAS UNSPECIFIED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209745 ↗
• MalfunctionApr 19, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN CANNULA, THE CUSTOMER REPORTED A BREAK AT THE PLASTIC END OF THE CANNULA. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO BLOOD LOSS, AS THE CRACK WAS OBSERVED IMMEDIATELY UPON CANNULATION. NO TRANSFUSION WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141250 ↗
• MalfunctionMar 23, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN CANNULA, THE CUSTOMER REPORTED THAT THE CONNECTOR WAS BROKEN. 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 13861968 ↗