Bio-Medicus™ 96830-110Recalls & reported problems
Medtronic, Inc. · CANNULA 96830-110 BIO-MED VEN 10FR · Class 2
All models of Bio-Medicus (59)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000116347), received between Mar 21, 2024 and Mar 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (1 report).
1 other recall cover devices cleared under the same FDA submission (K143083); they may or may not involve this specific model.
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
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2024Mechanical Problem; Material Deformation; Packaging Problem; Mechanical Problem; Material Deformation; Packaging Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN PEDIATRIC VENOUS CANNULA, IT WAS REPORTED THAT APPROXIMATELY 6-8 INCHES FROM THE DISTAL TIP OF THE CANNULA WAS BENT BADLY. THE CUSTOMER STATED THAT SHIPPING AND HANDLING DAMAGE CAUSED A SEVERE BEND IN THE CANNULA BODY AND THE INTRODUCER CANNOT BE PASSED THROUGH IT FOR INSERTION. THERE WAS DAMAGE TO THE OUTER PACKAGING. NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18947996 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143083. One submission often covers many models, so check the product and lot details in each record.
- Z-0640-2018 · Sep 21, 2017 · TerminatedGastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the applicati
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- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY11R00R6Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
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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