CO-SET+ 93600Recalls & reported problems
Edwards Lifesciences LLC · CO-SET DELIVERY SYSTEM FOR COLD INJECTATE · Class 2
- 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 07460691949997), received between Oct 30, 2024 and Oct 30, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination1
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.
MalfunctionOct 30, 2024Contamination; Contamination
AS REPORTED, WHEN FLUSHING THIS CO-SET CONNECTED TO A SWAN-GANZ CATHETER, A BLACK SUBSTANCE CAME OUT. THERE IS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHIC DATA WAS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20565293 ↗
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- PiCCO Catheter PV2014L16NPulsion Medical Systems SE · Probe, Thermodilution3 reports
- PiCCO Catheter PV2015L20NPulsion Medical Systems SE · Probe, Thermodilution1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.