Bio-Medicus® 96830-012Recalls & reported problems
Medtronic, Inc. · CANNULA 96830-012 BIO-MED VEN 12F EA 17L · 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 00613994530806), received between Sep 12, 2019 and Dec 11, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Mechanical Problem1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Sedation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS PEDIATRIC VENOUS CANNULA, IT WAS REPORTED THE INTRODUCER ON THE CANNULA WAS NOT FITTING CORRECTLY AND THE HUB LOOKED LIKE IT HAD ¿MELTED¿ OUT OF SHAPE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20900085 ↗InjurySep 12, 2019Off-Label Use; Off-Label Use
MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THEY HAD A NEONATE ON VA ECMO AND HAD PLACED A 12 FR BIO-MEDICUS ONE-PIECE FEMORAL VENOUS CANNULA. ON CHEST X-RAY AFTER TWO DAYS ON ECMO, THE CANNULA APPEARED ALMOST BROKEN. THE CUSTOMER DID A NECK EXPLORATION AND THE CANNULA WAS KINKED AND TORQUED AT THE SUTURE LINE, IN A WAY THE CUSTOMER HAD NOT SEEN PREVIOUSLY. THE PATIENT HAD TO COME OFF ECMO TO REMOVE THE CANNULA AND REPLACE IT. PATIENT WAS SUBJECTED TO SEDATION AND AN ADDITIONAL SURGICAL PROCEDURE. PATIENT STATUS AT THE TIME OF REPORTING WAS: ALIVE - NO INJURY.
Patient problems: Sedation
MAUDE report 9005545 ↗
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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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