Bio-Medicus™ 96570-117 (UDI 00763000947132)Recalls & reported problems
Medtronic, Inc. · CANNULA 96570-117 BIO-MEDICUS 17FR · Class 2
All models of Bio-Medicus (59)
Data updated Oct 16, 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 00763000947132), received between Dec 3, 2025 and Mar 11, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Insufficient Device Problem Information1
- Material Integrity Problem1
- 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.
MalfunctionMar 11, 2026Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT A CRACK WAS FOUND ON THE CONNECTOR UPON OPENING THE PACKAGE. THE DEVICE WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567614 ↗MalfunctionDec 29, 2025Material Puncture/Hole; Material Puncture/Hole
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA AND KITS, IT WAS REPORTED THAT THERE WAS SIGNS OF CRACKING AT THE END OF THE NG FEMORAL ARTERY CANNULA DEVICE DURING PREOPERATIVE CANNULATION PREPARATION FOR A MINIMALLY INVASIVE CARDIAC SURGERY. SEE ATTACHED PHOTOS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23906344 ↗MalfunctionDec 3, 2025Crack; Mechanical Problem; Insufficient Device Problem Information; Crack; Mechanical Problem; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL/JUGULAR VENOUS CANNULA WAS DEF ECTIVE. THE USE OF THE DEVICE WAS UNSPECIFIED. IT IS UNKNOWN IF THERE WAS ANY ADVERSE PATIENT EFFECTS REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707891 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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