Bio-Medicus™ 96570-115 (UDI 00643169025783)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169025783), received between May 25, 2023 and Jun 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Crack; Fluid/Blood Leak; Material Puncture/Hole; Crack; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA AND KITS, IT WAS REPORTED THAT AFTER INTUBATION WAS INSTALLED, THE TUBE WAS TAKEN OVER ONE AFTER ANOTHER. AFTER REMOVING THE HEMOSTATIC VALVE, IT WAS FOUND THAT THE MAIN TUBE WAS CRACKED AND LEAKING BLOOD. SEE ATTACHED PHOTO. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 19535983 ↗
• MalfunctionJun 30, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CANNULA IN SURGERY, THE CUSTOMER OBSERVED A CRACK AT THE TIP OF THE CANNULA, DURING INSERTION. THE CANNULA WAS REMOVED AND REPLACED WITH A NEW CANNULA TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION FROM THE SALES REP: THE HEMOSTASIS CAP WAS USED AND REMOVED WITH THE INTRODUCER DURING THE INSERTION OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236903 ↗
• MalfunctionMay 25, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS CANNULA, THE CUSTOMER REPORTED THAT THE CANNULA WAS CRACKED AT THE HUB. THERE WAS A 1/2 INCH VISIBLE CRACK 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 17002436 ↗