Bio-Medicus Life Support™ LS96360-027Recalls & reported problems
Medtronic, Inc. · CATHETER LS96360-027 BIO-MED VEN 27FR · Class 2
All models of Bio-Medicus Life Support (16)
Data updated Oct 18, 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 00763000615598), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- 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.
MalfunctionSep 30, 2026Mechanical Problem
It was reported that during insertion of a Bio-Medicus Life Support cannula, there was difficulty removing the cannula dilator. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949247 ↗
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™ LS96218-015Medtronic, Inc. · Single lumen ECMO cannula4 reports
- Bio-Medicus Life Support™ LS96555-021Medtronic, Inc. · Single lumen ECMO cannula4 reports
- Bio-Medicus Life Support™ LS96360-023Medtronic, Inc. · Single lumen ECMO cannula3 reports
- Bio-Medicus Life Support™ LS96555-023Medtronic, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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