PiCCO Catheter PV2014L16NRecalls & reported problems
Pulsion Medical Systems SE · 4F Thermodilution catheter, 16cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04250094500658), received between Nov 21, 2019 and Dec 18, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 reports).
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.
Most reported problems
Device problems
- Leak/Splash3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2020Leak/Splash; Leak/Splash
MANUFACTURER REFERENCE #: (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11035547 ↗MalfunctionJul 23, 2020Leak/Splash; Leak/Splash
MANUFACTURER REFERENCE #: (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10312549 ↗MalfunctionNov 21, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER HAVING PLACED THE PICCO CATHETER FEMORAL A CRACK WAS FOUND IN THE LUER LOCK CONNECTION. THE CATHETER WAS EXCHANGED IMMEDIATELY. NO CONSEQUENCES OR HARM TO THE PATIENT OCCURRED. MANUFACTURER REFERENCE: (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9353386 ↗
Other Probe, Thermodilution devices
- PiCCO Catheter PV2015L20-APulsion Medical Systems SE · Probe, Thermodilution24 reports
- PiCCO Catheter PV2014L16-APulsion Medical Systems SE · Probe, Thermodilution16 reports
- CO-SET+ 93505Edwards Lifesciences LLC · PROBE, THERMODILUTION9 reports
- PiCCO Catheter PV2014L22-APulsion Medical Systems SE · Probe, Thermodilution8 reports
- VolumeView VLV8R520Edwards Lifesciences LLC · PROBE, THERMODILUTION4 reports
- CO-SET+ 93522Edwards Lifesciences LLC · PROBE, THERMODILUTION3 reports
- PiCCO Catheter PV2015L20NPulsion Medical Systems SE · Probe, Thermodilution1 report
- PiCCO Catheter PV2013L07-APulsion Medical Systems SE · Probe, Thermodilution1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page