Bio-Medicus™ 96570-123Recalls & reported problems
Medtronic, Inc. · CANNULA 96570-123 BIO-MEDICUS 23FR EA · Class 2
All models of Bio-Medicus (59)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000116118), received between Apr 19, 2023 and Jan 8, 2026 — classified as 1 injury, 1 malfunction.
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
- Misassembled During Installation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026Crack
IT WAS REPORTED THAT AFTER INSERTING THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL/JUGULAR VENOUS CANNULA INTO THE FEMORAL VEIN DURING AN ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) PROCEDURE, A 1/2" CRACK WAS IDENTIFIED ON THE CONNECTOR OF THE CANNULA. THE CRACK WAS NOT ATTRIBUTED TO THE CANNULATION PROCESS OR THE USE OF CLAMPS, AND THE PACKAGING WAS UNDAMAGED PRIOR TO USE. THE DAMAGE WAS NOT LOCATED NEAR THE SUTURES. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003205 ↗InjuryApr 19, 2023Misassembled During Installation; Misassembled During Installation
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT THE VEIN NEEDLE HAD A WRONG CONNECTOR, 1/2-3/8 PART INSTEAD OF 3/8-3/8. IT COULD THEREFORE NOT CONNECT TO THE HOSE SETS ON THE EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) MACHINE, SO IT TOOK APPROXIMATELY 5 MINUTES BEFORE THE PATIENT WAS CONNECTED TO ECMO. THE CORRECT CONNECTOR HAD TO BE FOUND, AND THE WRONG CONNECTOR HAD TO BE CUT OUT DURING THE STERILE PROCEDURE WHILE THE VENOUS CANNULA WAS IN THE PATIENT'S LEFT GROIN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16766728 ↗
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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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