PiCCO Catheter PV2014L22-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04250094500979), received between Apr 21, 2021 and Mar 5, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN INSERTING THE CATHETER, THE NEEDLE TIP (PINK) GOT CAUGHT ON THE GUIDE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525692 ↗
• MalfunctionNov 7, 2024Stretched; Unraveled Material; Stretched; Unraveled Material

  MANUFACTURER REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628507 ↗
• MalfunctionNov 7, 2024Stretched; Unraveled Material; Stretched; Unraveled Material

  MANUFACTURER REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628497 ↗
• MalfunctionAug 29, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE USER REPORT FROM THE FEDERLA INSTITUTE FOR DRUGS AN MEDICAL DEVICES GERMANY : WHEN INSTALLING THE ABOVE-MENTIONED CATHETER (PV2014L22-A, PICCO CATHETER 4F, 22CM, LOT 708891), AFTER INSERTING THE GUIDE WIRE, THE DILATOR COULD NOT BE THREADED ONTO THE NITINOL SELDINGER WIRE DUE TO RESISTANCE IN THE PROXIMAL LUMEN. THE STENOSIS APPEARS TO BE AT THE TRANSITION FROM THE LUER CONNECTOR TO THE DILATOR SHAFT. BY USING A NEW SET WITH A DIFFERENT DILATOR, THE CATHETER COULD FINALLY BE PLACED. THE PROCEDURE WAS PROLONGED AS A RESULT, AND ACCORDING TO THE CURRENT FINDINGS, NO HARM TO THE PATIENT CAN BE ASSUMED. THE CATHETER ITSELF WAS PRESERVED FOR THE EXAMINATION TOGETHER WITH THE DILATOR AND NITINOL-SELDINGER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642039 ↗
• InjuryNov 26, 2022Material Fragmentation; Material Fragmentation

  IT HAS BEEN REPORTED THAT PART OF THE CATHETER TIP FROM THE GUIDE WIRE REMAINED IN THE PATIENT'S VESSEL AND HAD TO BE REMOVED. MANUFACTURER REFERENCE: #(B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15866918 ↗
• InjuryNov 24, 2022Material Fragmentation; Material Fragmentation

  IT HAS BEEN REPORTED THAT PART OF THE CATHETER TIP FROM THE GUIDE WIRE REMAINED IN THE PATIENT'S VESSEL AND HAD TO BE REMOVED. MANUFACTURER REFERENCE: (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15860404 ↗
• MalfunctionApr 21, 2021Break; Break

  A CATHETER HAS BEEN PLACED RIGHT FEMORAL ON (B)(6) 2021. IMMEDIATELY NO MEASUREMENTS POSSIBLE. THERE WAS NO TEMPERATURE READING. ON (B)(6) 2021 FINALLY SUCCEEDED IN ONE MEASUREMENT. NO LEAKAGE DETECTED FOR THIS CATHETER. ON (B)(6) 2021 NEW PICCO CATHETER HAS BEEN PLACED BRACHIAL UNDER ECHO ON THE LEFT. ONE MEASUREMENT SUCCESSFUL, CATHETER NOT DETECTED AFTERWARDS. ON (B)(6) 2021 IT HAS BEEN DETECTED VISUALLY THAT THERE IS BLOOD IN THE WHITE CONNECTION CABLE. THE CASE IS REPORTED AS LEAKING PARTS IN CONTACT WITH ARTERIAL BLOOD PRESSURE HAVE BEEN REPORTED. NO HARM OR CLINICAL CONSEQUENCES OCCURRED TO THE PATIENT. MANUFACTURER REFERENCE: #(B)(4). ON (B)(6) 2021, NEW CATHETER PLACED LEFT BRACHIAL AGAIN. ON THE NEXT DAY, AGAIN NO MEASUREMENT POSSIBLE. CATHETER NOT DETECTED. ON (B)(6) 2021 NO MEASUREMENTS POSSIBLE AT FIRST, BUT A FEW HOURS LATER. A LEAKAGE IN THE WHITE CONNECTION CABLE HAS BEEN DETECTED FOR THIS CATHETER AS WELL. THE CASE WAS EVALUATED AS REPORTABLE AS LEAKING PARTS IN CONTACT WITH ARTERIAL BLOOD PRESSURE HAVE BEEN REPORTED (REFER TO REPORT WITH MANUFACTURER REFERENCE #(B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698874 ↗
• MalfunctionApr 21, 2021Break; Break

  MANUFACTURER REFERENCE: # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698872 ↗