PiCCO Catheter PV2015L20NRecalls & reported problems
Pulsion Medical Systems SE · 5F Thermodilution catheter, 20cm · Class 2
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 04250094500672), received between Feb 11, 2021 and Feb 11, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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.
Most reported problems
Device problems
- Incomplete or Missing Packaging1
- Insufficient Device Problem Information1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2021Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information
MANUFACTURER REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11312552 ↗
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 PV2014L16NPulsion Medical Systems SE · Probe, Thermodilution3 reports
- 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.
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