PiCCO Catheter PV2015L20-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04250094500931), received between Oct 25, 2019 and Apr 29, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Stretched

  IT WAS REPORTED THAT PICCO CATHETER WAS STUCK AND IT WAS ONLY POSSIBLE TO REMOVE IT AFTER MULTIPLE ATTEMPTS. THE WIRE FELL APART. THERE WAS NO PATIENT HARM. MANUFACTURER REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031370 ↗
• MalfunctionMar 24, 2026Stretched

  IT WAS REPORTED THAT PICCO CATHETER CAUSED PROBLEMS DURING INSERTION: THE GUIDEWIRE SPRING GOT STUCK IN THE PATIENT'S FEMORAL ARTERY. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673369 ↗
• MalfunctionMar 11, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT PICCO CATHETER HAD A CRACK RESULTING IN LEAKAGE AFTER THE FIXATION WING DURING INJECTION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574043 ↗
• InjuryJan 30, 2026Stretched

  IT WAS REPORTED THAT DURING PLACEMENT OF PICCO CATHETER THE RESISTANCE WAS ENCOUNTERED, THEREFORE THE WIRE WAS WITHDRAWN. DURING WITHDRAWAL, RESISTANCE WAS ENCOUNTERED ALONG ITS COURSE; THE WIRE COULD NEITHER BE MOVED FORWARD NOR BACKWARD. THE WIRE ALMOST COMPLETELY BROKE AT THE LEVEL OF THE PIGTAIL, REMAINING CONNECTED TO THE TIP OF THE PIGTAIL ONLY BY A STRAND OF WIRE APPROXIMATELY THE THICKNESS OF A HAIR. THROUGH AN EXTENDED SKIN INCISION, IT IS POSSIBLE TO RETRIEVE THE TIP OF THE SELDINGER WIRE, PROBABLY COMPLETELY. FINAL PATIENT OUTCOME IS UNKNOWN. MANUFACTURER REFERENCE # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 24222927 ↗
• MalfunctionJan 30, 2026Stretched

  IT WAS REPORTED THAT DURING PLACEMENT OF PICCO CATHETER THE RESISTANCE WAS ENCOUNTERED, THEREFORE THE WIRE WAS WITHDRAWN. DURING WITHDRAWAL, RESISTANCE WAS ENCOUNTERED ALONG ITS COURSE; THE WIRE COULD NEITHER BE MOVED FORWARD NOR BACKWARD. THE WIRE ALMOST COMPLETELY BROKE AT THE LEVEL OF THE PIGTAIL, REMAINING CONNECTED TO THE TIP OF THE PIGTAIL ONLY BY A STRAND OF WIRE APPROXIMATELY THE THICKNESS OF A HAIR. THROUGH AN EXTENDED SKIN INCISION, IT IS POSSIBLE TO RETRIEVE THE TIP OF THE SELDINGER WIRE, PROBABLY COMPLETELY. FINAL PATIENT OUTCOME IS UNKNOWN. MANUFACTURER REFERENCE # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 24219514 ↗
• MalfunctionJan 30, 2026Crack

  IT WAS REPORTED THAT PICCO CATHETER HAD A CRACK, RESULTING IN FLUID LEAKAGE. THE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219471 ↗
• MalfunctionJun 17, 2025Stretched; Stretched

  IT WAS REPORTED THAT DURING INSERTION PROCEDURE GUIDEWIRE UNCOILED. NO HARM TO PATIENT REPORTED TO THE DATE OF SUBMITTING THIS REPORT. SEVERED GUIDE WIRE WAS RETRIEVED WITHOUT SURGICAL INTERVENTION. MANUFACTURER REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229218 ↗
• MalfunctionMay 7, 2025Stretched; Material Deformation; Stretched; Material Deformation

  IT WAS REPORTED THAT THE SPIRAL GUIDEWIRE UNCOILED WHEN REMOVING FROM THE CATHETER. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976219 ↗
• MalfunctionMar 24, 2025Stretched; Stretched

  MANUFACTURER REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675509 ↗
• MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  PACIENTE CON INESTABILIDAD HEMODINAMICA, POR INDICACIÓN MEDICA SE REALIZA SOLICITUD DE CATETER PICCO PARA MONITORIA HEMODINAMICA INVASIVA. EN EL MOMENTO DE REALIZAR LA CONEXIÓN A LINEA ARTERIAL FEMORAL DERECHA, SE OBSERVA FUGA DE LIQUIDO EN EL TRANSDUCTOR ARTERIAL, SE REALIZA VERIFICACIÓN DEL MISMO, EN 3 OPORTUNIDADES, SE AJUSTAN LLAVES, SIN EMBARGO PERSISTE EL INCIDENTE, POR TAL MOTIVO NO SE LOGRA TOMAR HEMODINAMIA DEL PACIENTE Y REQUIERE CAMBIO DEL DISPOSITIVO MEDICO EL CUAL FUNCIONA CORRECTAMENTE. THIS IS AN AUTOMATED DRAFT TRANSLATION - IF ANY UNCERTAINTY CONTACT THE LOCAL SSU IMMEDIATELY: PATIENT WITH HEMODYNAMIC INSTABILITY, DUE TO MEDICAL INDICATION, A PICCO CATHETER IS REQUESTED FOR INVASIVE HEMODYNAMIC MONITORING. AT THE TIME OF MAKING THE CONNECTION TO THE RIGHT FEMORAL ARTERIAL LINE, A FLUID LEAK IS OBSERVED IN THE ARTERIAL TRANSDUCER, IT IS VERIFIED ON 3 OCCASIONS, KEYS ARE ADJUSTED, HOWEVER THE INCIDENT PERSISTS, FOR THIS REASON IT IS NOT POSSIBLE TO TAKE THE PATIENT'S HEMODYNAMICS AND A CHANGE OF THE MEDICAL DEVICE IS REQUIRED, WHICH WORKS CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525687 ↗
• MalfunctionSep 30, 2024Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  MANUFACTURER REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333126 ↗
• InjuryJan 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE INSERTING THE GUIDEWIRE THROUGH THE NEEDLE (PINK) IN A PATIENT WITH SEVERE ARTERIOSCLEROSIS, THE GUIDEWIRE GOT STUCK IN THE CHALK OF THE ARTERY AND WHEN MANIPULATING THE GUIDEWIRE THROUGH THE NEEDLE, THE TIP WAS TORN OFF. THE DOCTOR INDICATED THAT THERE WAS SPACE BETWEEN THE NEEDLE AND THE GUIDEWIRE AND THIS, ALONG WITH THE ARTERIOSCLEROSIS WHICH WAS A DIFFICULT PROCEDURE, MAY HAVE BEEN THE CAUSE OF THIS INCIDENT. A CT SCAN WAS DONE TO LOCATE THE GUIDEWIRE , CONCLUSION: THE TIP OF THE GUIDEWIRE IS STILL IN THE PATIENT AND LOCATED OUTSIDE THE ARTERY. THE PATIENT AND HIS FAMILY WERE INFORMED. THE PATIENT WILL RETURN SOON FOR OUTPATIENT VISIT AFTER ADMISSION TO THE ICU.

  Patient problems: Foreign Body In Patient

  MAUDE report 18424955 ↗
• InjuryJan 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE INSERTING THE GUIDEWIRE THROUGH THE NEEDLE (PINK) IN A PATIENT WITH SEVERE ARTERIOSCLEROSIS, THE GUIDEWIRE GOT STUCK IN THE CHALK OF THE ARTERY AND WHEN MANIPULATING THE GUIDEWIRE THROUGH THE NEEDLE, THE TIP WAS TORN OFF. THE DOCTOR INDICATED THAT THERE WAS SPACE BETWEEN THE NEEDLE AND THE GUIDEWIRE AND THIS, ALONG WITH THE ARTERIOSCLEROSIS WHICH WAS A DIFFICULT PROCEDURE, MAY HAVE BEEN THE CAUSE OF THIS INCIDENT. A CT SCAN WAS DONE TO LOCATE THE GUIDEWIRE , CONCLUSION: THE TIP OF THE GUIDEWIRE IS STILL IN THE PATIENT AND LOCATED OUTSIDE THE ARTERY. THE PATIENT AND HIS FAMILY WERE INFORMED. THE PATIENT WILL RETURN SOON FOR OUTPATIENT VISIT AFTER ADMISSION TO THE ICU.

  Patient problems: Foreign Body In Patient

  MAUDE report 18424503 ↗
• MalfunctionSep 8, 2023Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  MANUFACTURER REF. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17708971 ↗
• MalfunctionAug 30, 2023Material Fragmentation; Material Fragmentation

  IT HAS BEEN REPORTED, THAT DURING THE PUNCTURE OF THE RIGHT BRACHIAL ARTERY UNDER SONOGRAPHIC CONTROL. THE INSERTION OF THE SELDINGER WIRE AND PASSAGE OVER CANNULA WAS NOT POSSIBLE. THE WIRE PENETRATES ONLY ABOUT 1.5-2CM. IT WAS DIFFICULT TO REMOVE THE GUIDEWIRE. THE GUIDEWIRE HAS BEEN UNRAVELED. TOTAL WIRE COMPLETELY REMOVED AT THE END. NO HARM OR CLINICAL CONSEQUENCES TO PATIENT OR USER HAVE BEEN REPORTED. MANUFACTURER REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649848 ↗
• MalfunctionDec 20, 2022Material Fragmentation; Material Fragmentation

  IT HAS BEEN REPORTED THAT AFTER PUNCTURE OF THE RIGHT FEMORAL ARTERY (WITHOUT ANY PROBLEMS), THE SELDINGER WIRE OF THE PICCO CATHETER CANNOT BE PUSHED OUT OVER THE NEEDLE, AT THE END OF THE NEEDLE LUMEN IT CANNOT BE ADVANCED OR RETRACTED. REMOVED THE NEEDLE AND WIRE AS A WHOLE AND SAW THAT THE WIRE WAS SPLIT. NO PROBLEMS DURING PUNCTURE WITH NEW SET. NO HARM OR CLINICAL CONSEQUENCES TO PATIENT OR USER HAVE BEEN REPORTED. THE INDICATION FOR THE USE OF PICCO WAS CARDIOGENIC SHOCK. THE PATIENT DIED A FEW DAYS LATER IN CARDIOGENIC SHOCK. WITH REGARD TO THE PICCO, THERE WERE NO PROBLEMS. MANUFACTURER REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16012076 ↗
• MalfunctionSep 13, 2022Break; Material Fragmentation; Break; Material Fragmentation

  IT HAS BEEN REPORTED THAT DURING INSERTION VIA THE FEMORAL ROUTE ON AN ALREADY EXISTING ARTERIAL CATHETER ("MANDRAINING" ON AN ALREADY EXISTING CATHETER"), THE CATHETER FOR PICCO CRACKS WHEN PASSING THROUGH THE GUIDE. THE DOCTOR WAS OBLIGED TO REMOVE THE CATHETER AND GUIDE, AND TO CHANGE THE PICCO CATHETER. SUCCESS OF THE PROCEDURE BY CHANGING THE CATHETER. NO CLINICAL CONSEQUENCES HAVE BEEN OBSERVED. MANUFACTURER REFERENCE: #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409986 ↗
• MalfunctionDec 9, 2021Material Fragmentation; Material Fragmentation

  THE FOLLOWING HAS BEEN REPORTED: "I AM INVESTIGATING A DATIX RELATING TO A PICCO CATHETER THAT WAS INSERTED ON A PATIENT IN OUR UNIT. WHEN THE DOCTOR WAS REMOVING THE GUIDEWIRE HAVING SUCCESSFULLY PLACED THE LINE IT WAS NOTED THAT THE GUIDEWIRE HAD UNRAVELED. THE DOCTOR AND A SISTER ON THE UNIT BOTH INSPECTED THE GUIDEWIRE AND FELT THAT IT WAS INTACT. THERE WERE NO PARTICULAR PROBLEMS DURING INSERTION OR ON REMOVAL OTHER THAN THE ISSUE WITH THE GUIDEWIRE ITSELF. THERE WERE NO PROBLEMS WITH INSERTION OR RETRACTION OF THE NEEDLE." THE PROVIDED PICTURE INDICATES THAT THE GUIDEWIRE UNCOILED. NO HARM OR CLINICAL CONSEQUENCES OCCURRED. MANUFACTURER REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967597 ↗
• MalfunctionMay 21, 2021Material Fragmentation; Material Fragmentation

  MANUFACTURER REFERENCE: #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861490 ↗
• MalfunctionMay 7, 2021Break; Break

  MANUFACTURER REFERENCE: # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788834 ↗
• MalfunctionMar 31, 2021Break; Material Fragmentation; Break; Material Fragmentation

  MANUFACTURER REFERENCE: #(B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594791 ↗
• MalfunctionFeb 17, 2020Material Fragmentation; Material Fragmentation

  MANUFACTURER REFERENCE #: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716692 ↗
• MalfunctionOct 25, 2019Material Fragmentation; Material Fragmentation

  MANUFACTURER REFERENCE #: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9237327 ↗
• MalfunctionOct 25, 2019Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER ULTRASOUND DRIVEN FEMORAL PUNCTURE, THE END OF THE GUIDEWIRE GOT ALMOST BROKEN. AFTER THE DILATATION AND INSERTION OF THE CANNULA, IT WAS NOT FEASIBLE TO PULL THE GUIDE WIRE OUT, ONLY WITH THE CANNULA. THE DAMAGE OF THE GUIDEWIRE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. NO CLINICAL CONSEQUENCES OR HARM TO THE PATIENT OCCURRED. INSERTION OF A NEW CATHETER WAS NEEDED. MANUFACTURER REFERENCE #: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9237326 ↗