BioMedicus™ 96670-117Recalls & reported problems
Medtronic, Inc. · CANNULA 96670-117 BIO-MEDICUS 17FR EA · Class 2
All models of BioMedicus (5)
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 00643169025998), received between Jun 30, 2023 and Jul 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
- Crack1
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.
MalfunctionJul 3, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING USE OF THESE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULAE, THE WHITE MANDREL DID NOT SLIDE INTO THE CANNULAE, PREVENTING IT FROM BEING PULLED OUT. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395296 ↗MalfunctionJul 3, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING USE OF THESE BIO-MEDICUS NEXTGEN MULTI-STAGE FEMORAL VENOUS CANNULAE, THE WHITE MANDREL DID NOT SLIDE INTO THE CANNULAE, PREVENTING IT FROM BEING PULLED OUT. THE DEVICES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395289 ↗MalfunctionJun 30, 2023Crack; Crack
MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE TIP OF THE 17FR BIO-MEDICUS CANNULA WAS CRACKED. THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION: 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 17236947 ↗
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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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