Bio-Medicus Life Support™ LS96010-009Recalls & reported problems
Medtronic, Inc. · CATHETER LS96010-009 BIO-MED ART 9FR · Class 2
All models of Bio-Medicus Life Support (16)
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 00763000615338), received between Mar 25, 2026 and Mar 25, 2026 — classified as 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
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 25, 2026Mechanical Problem; Material Deformation
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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688899 ↗
Other Single lumen ECMO cannula devices
- Bio-Medicus Life Support™ LS96218-017Medtronic, Inc. · Single lumen ECMO cannula8 reports
- Bio-Medicus Life Support™ LS96555-019Medtronic, Inc. · Single lumen ECMO cannula7 reports
- Bio-Medicus Life Support™ LS96360-025Medtronic, Inc. · Single lumen ECMO cannula5 reports
- Bio-Medicus Life Support™ LS96218-019Medtronic, Inc. · Single lumen ECMO cannula5 reports
- Bio-Medicus Life Support™ LS96555-021Medtronic, Inc. · Single lumen ECMO cannula4 reports
- Bio-Medicus Life Support™ LS96218-015Medtronic, Inc. · Single lumen ECMO cannula4 reports
- Bio-Medicus Life Support™ LS96555-023Medtronic, Inc. · Single lumen ECMO cannula3 reports
- Bio-Medicus Life Support™ LS96360-023Medtronic, Inc. · Single lumen ECMO cannula3 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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