Bio-Medicus Life Support™ LS96550-015Recalls & reported problems
Medtronic, Inc. · CATHETER LS96550-015 BIO-MED VEN 15FR · 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 00763000615475), received between Mar 18, 2025 and Mar 18, 2025 — classified as 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Material Deformation1
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 18, 2025Crack; Material Deformation; Crack; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE END OF THE CANNULA WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21632916 ↗
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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