Bio-Medicus™ 96670-123 (UDI 00763000060626)Recalls & reported problems
Medtronic, Inc. · CANNULA 96670-123 BIO-MEDICUS MS 23FR · Class 2 · Implant
All models of Bio-Medicus (59)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000060626), received between Jul 3, 2024 and Dec 22, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Contamination1
- Crack1
- Material Deformation1
- Material Puncture/Hole1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA AND KIT, IT WAS REPORTED THAT THE TAIL END OF THE CANNULA WAS CRACKED AND THE INTRODUCER COULD NOT BE PULLED OUT. SEE ATTACHED PHOTO. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862083 ↗MalfunctionMay 19, 2025Crack; Crack
IT WAS REPORTED THAT DURING A PREOPERATIVE CHECKUP, THE PLASTIC ON THE CANNULA CLAMP OF THE BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA WAS FOUND TO BE BROKEN. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22042215 ↗MalfunctionJul 3, 2024Contamination; Material Deformation; Contamination; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIOMEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THERE WAS A WHITE APPEARANCE ON DEVICE. SEE ATTACHED PHOTO. THE CUSTOMER DECIDED TO REMOVE THE PIECE FROM THE DEVICE AND REPLACE IT WITH A 3/8 STRAIGHT CONNECTOR AND CONTINUE TO USE THE DEVICE. 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 19664502 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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