PiCCO Catheter PV2014L16-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04250094500962), received between Nov 20, 2019 and Dec 19, 2025 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Stretched; Stretched

  IT WAS REPORTED THAT A SECTION OF THE PICCO GUIDEWIRE SHEARED OFF AND REMAINED WITHIN A PATIENT. PICCO LINE INSERTED INTO RIGHT FEMORAL ARTERY. DURING INITIAL AND SECOND IT WAS IMPOSSIBLE TO PASS GUIDEWIRE AND LINE BECAME DIFFICULT TO EXTRACT. SECOND CLINICIAN ATTEMPTED TO REMOVE THE LINE WITH GENTLE ROTATION. THE WIRE WAS REMOVED BUT ON REMOVAL OF THE NEEDLE FROM THE SKIN THERE WAS UNRAVELED WIRE VISIBLE AT THE SKIN PUNCTURE SITE. ULTRASOUND AND CT HAVE CONFIRMED PART OF THE WIRE IN THE SUBCUTANEOUS TISSUES AND VESSEL. FINAL PATIENT OUTCOME IS UNKNOWN. MANUFACTURER REFERENCE # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 23850467 ↗
• InjuryDec 18, 2025Stretched; Stretched

  IT WAS REPORTED THAT A SECTION OF THE PICCO GUIDEWIRE SHEARED OFF AND REMAINED WITHIN A PATIENT. PICCO LINE INSERTED INTO RIGHT FEMORAL ARTERY. DURING INITIAL AND SECOND IT WAS IMPOSSIBLE TO PASS GUIDEWIRE AND LINE BECAME DIFFICULT TO EXTRACT. SECOND CLINICIAN ATTEMPTED TO REMOVE THE LINE WITH GENTLE ROTATION. THE WIRE WAS REMOVED BUT ON REMOVAL OF THE NEEDLE FROM THE SKIN THERE WAS UNRAVELED WIRE VISIBLE AT THE SKIN PUNCTURE SITE. ULTRASOUND AND CT HAVE CONFIRMED PART OF THE WIRE IN THE SUBCUTANEOUS TISSUES AND VESSEL. FINAL PATIENT OUTCOME IS UNKNOWN. MANUFACTURER REFERENCE # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 23837748 ↗
• MalfunctionNov 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PUNCTURE NEEDLE CONNECTOR HAD CRACKED WHEN CONNECTING THE SYRINGE, CAUSING BLOOD TO FLOW OUT FROM THE CRACK. NO HARM TO PATIENT WAS REPORTED. THE MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462738 ↗
• InjuryNov 3, 2025Stretched; Stretched

  MANUFACTURER REFERENCE # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 23450680 ↗
• InjuryOct 31, 2025Stretched; Stretched

  IT WAS REPORTED THAT DUE TO PATIENT CONDITIONS PICCO TECHNOLOGY WAS DECIDED TO BE USED. THE INSERTION OF NEEDLE PROCEEDED SMOOTHLY. DURING GUIDEWIRE INSERTION, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE GUIDEWIRE WAS SUBSEQUENTLY WITHDRAWN BUT MET RESISTANCE. UPON REMOVAL OF THE PUNCTURE NEEDLE, IT WAS DISCOVERED THAT THE GUIDEWIRE HAD BECOME UNCOILED AND COULD NOT BE RETRIEVED. DUE TO PATIENT'S PHYSICAL AND MEDICAL CONDITION PRIOR TO EVENT, WHICH MIGHT HAVE CONTRIBUTED TO ADHESION OR INCARCERATION OF THE UNWOUND GUIDEWIRE WITHIN THE VASCULAR WALL OR SURROUNDING TISSUES, IT WAS DECIDED NEED FOR SURGICAL INTERVENTION TO REMOVE GUIDEWIRE. THE PATIENT¿S STATE REMAINED STABLE. MANUFACTURER REFERENCE # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 23433764 ↗
• MalfunctionJul 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  OUR QA COLLEAGUE FOUND ON CHINA NATIONAL MEDICAL DEVICE ADVERSE EVENT MONITORING INFORMATION SYSTEM THAT THE CLINICIAN NOTICED BLOOD FLOWED BACKWARD THE RED CONNECTOR OF THE CATHETER PV2014L16-A. THERE WAS NO IMPACT ON PATIENT SAFETY, BUT THERE WAS AN IMPACT ON MEASUREMENT ACCURACY. MANUFACTURER REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728125 ↗
• MalfunctionFeb 22, 2024Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS IN UNSTABLE HEMODYNAMICS AND THE DOCTOR WANTED MONITORING PICCO. DURING THE PLACEMENT PROCESS, THEY FOUND THAT IT WAS DIFFICULT TO INSERT THE GUIDE WIRE INTO THE VESSEL VIA THE CANNULA, THE END WAS OBVIOUSLY BENT, SO THEY COULDN'T CONTINUE TO OPERATE. THEN THEY OPENED ANOTHER PACKAGE OF PICCO CATHETER TO FINISH THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757283 ↗
• MalfunctionDec 6, 2023Material Fragmentation; Material Fragmentation

  DURING THE PROCESS OF INSERTING THE CATHETER FOR THE PATIENT, THE INSERTION GUIDE WIRE WAS DAMAGED, THE EXTERNAL SPRING GUIDE WIRE WAS LOOSE, AND IT COULD NOT BE INSERTED. THE CATHETER FAILED TO BE INSERTED, AND THE CATHETER WAS RE-INSERTED. NO PATIENT HARM OR CLINICAL CONSEQUENCES TO THE PATIENT HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273692 ↗
• MalfunctionOct 27, 2023Material Integrity Problem; Material Integrity Problem

  MANUFACTURER REF.: #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18018689 ↗
• MalfunctionJul 19, 2023Material Fragmentation; Material Fragmentation

  MANUFACTURER REF.: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17348366 ↗
• MalfunctionMay 23, 2023Material Fragmentation; Material Fragmentation

  PATIENTS WITH SEPTIC SHOCK REQUIRE PICCO CATHETERIZATION TO MONITOR CARDIAC OUTPUT USE THE V2014L16-A KIT IN THE REPORT; DURING FEMORAL ARTERY PUNCTURE, ADJUSTING THE GUIDE WIRE WHEN IT WAS DISCOVERED THAT THE GUIDE WIRE WAS STUCK IN THE PUNCTURE NEEDLE, IT WAS FOUND THAT THE GUIDE WIRE ENTERED THE VASCULAR END AND WAS DAMAGED AFTER THE NEEDLE WAS CONNECTED AND WITHDRAWN. THEREFORE, THE GUIDE WIRE WAS IMMEDIATELY REPLACED WITHOUT CAUSING ANY DAMAGE TO THE PATIENT. MANUFACTURER REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982521 ↗
• MalfunctionOct 26, 2022Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THAT DURING NORMAL USE, THE CATHETER CONNECTOR (LUER LOCK) NEEDS TO BE TWISTED DUE TO DISINFECTION AND THE CATHETER CONNECTION IS BROKEN. THE ISSUE HAS OCCURRED DURING USE ON A PATIENT. NO HARM OR CLINICAL CONSEQUENCES OCCURRED. THERE WAS A BLOOD LEAKAGE OF 3ML, WHEN THE PRODUCT SPLIT. MANUFACTURER REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672187 ↗
• MalfunctionMar 15, 2022Material Fragmentation; Material Fragmentation

  THE FOLLOWING HAS BEEN REPORTED: USE PROCESS: WHEN THE PATIENT NEEDS TO USE IT DUE TO HIS OR HER CONDITION, FOLLOW THE INSTRUCTIONS FOR USE. DURING THE PUNCTURE PROCESS, THE DOCTOR SEES BLOOD RETURNING AND THERE IS RESISTANCE WHEN SENDING THE GUIDE WIRE. AFTER INSPECTION, IT IS FOUND THAT THE FRONT END OF THE GUIDE WIRE IS 2CM AWAY. VISIBLE 0.5CM SURFACE ROUGHNESS. THE FOLLOWING FURTHER INFORMATION HAS BEEN PROVIDED: 5-10 ML BLOOD LOSS REPORTED: A SMALL AMOUNT OF BLEEDING OCCURS DURING THE PUNCTURE AND IS WITHIN THE NORMAL LIMITS. NO LEAKAGE OF A CATHETER OCCURRED. THE PROCEDURE HAS BEEN STOPPED, WHEN RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE GUIDEWIRE. A NEW CATHETER HAS BEEN INSERTED. THERE ARE NO FURTHER CONSEQUENCES DUE TO THIS ISSUE FOR PATIENT AND TREATMENT. NO PARTS REMAINED IN THE PATIENT. THE COMPLAINT IS EVALUATED AS REPORTABLE DUE TO THE DESCRIPTION ¿IT IS FOUND THAT THE FRONT END OF THE GUIDE WIRE IS 2 CM AWAY¿. BASED ON THAT IT CANNOT BE EXCLUDED THAT THE GUIDEWIRE UNCOILED OR PARTS SEPARATED. MANUFACTURER REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13768323 ↗
• MalfunctionSep 22, 2021Break; Break

  DURING INVESTIGATION OF A RETURNED PICCO CATHETER IT WAS DETECTED THAT THERE IS A CRACK IN THE BLUE LUMEN TUBING CLOSE TO THE CHANNEL SEPARATION. NO HARM OR CLINICAL CONSEQUENCES OCCURRED TO THE PATIENT. THE DEVICE WAS NOT USED ON A PATIENT WHEN THE ISSUE HAS BEEN DETECTED. LEAKING PARTS OF THE BLUE LUMEN TUBING ARE REGARDED AS AN EVENT THAT COULD LEAD TO SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. MANUFACTURER REFERENCE #:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511384 ↗
• MalfunctionFeb 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  MANUFACTURER REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11314136 ↗
• MalfunctionNov 20, 2019Material Fragmentation; Material Fragmentation

  (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346684 ↗