Bio-Medicus Life Support™ LS96438-025Recalls & reported problems
Medtronic, Inc. · CATHETER LS96438-025 BIO-MED VEN 25FR · 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 00763000615550), received between Jan 7, 2026 and Jan 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- 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.
MalfunctionJan 7, 2026Fluid/Blood Leak; Mechanical Problem; Material Deformation
IT WAS REPORTED THAT THE CONNECTOR OF THE BIO-MEDICUS LIFE SUPPORT CANNULA DID NOT CLOSE PROPERLY AND THE SHAPE OF THE CONNECTOR WAS UNUSUAL. THE CONNECTOR WAS REPLACED, AFTER WHICH IT FUNCTIONED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987960 ↗
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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