PowerPICC SOLO2 HF Catheter 1395108QDRecalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00801741034725), received between Apr 22, 2016 and Feb 12, 2026 — classified as 15 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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 25 most recent of 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT TWO DAYS AFTER PICC PLACEMENT, LEAKAGE AND A CRACK WERE OBSERVED AT ONE OF THE LUMENS. IT WAS REPORTED THAT THE PICC HAD BEEN PLACED ON (B)(6) 2026 WITH NO ISSUES NOTED AT THE TIME OF INSERTION, AND THE LEAKAGE WAS REPORTED ON (B)(6) 2026 BY NURSING STAFF. THE VASCULAR ACCESS CLINICIAN ON SHIFT DID NOT ASSESS THE LINE PRIOR TO REMOVAL, AND THE DEVICE WAS NOT RETAINED AND NO PHOTOS WERE TAKEN. THE PATIENT REPORTED NO PAIN, ONLY LEAKAGE UNDER THE DRESSING, AND THE RN REMOVED THE LINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323854 ↗
• MalfunctionJan 6, 2026Contamination /Decontamination Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHITE SUBSTANCE FOUND ON PICC LUMEN THREADING BEFORE INSERTION INTO PATIENT. NO IMPACT TO PATIENT, DELAY IN PROCEDURE AND NEW KIT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974030 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC IS LEAKING/CHANGING COLOR AT THE HUB. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667871 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT TRIPLE LUMEN PICC LEAKING UNDER THE SECURACATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22446107 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC IS BREAKING AND NOTICING LEAKING AT THE INSERTION. NO IMPACT KNOWN TO THE PATIENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396259 ↗
• MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC IS BREAKING AND NOTICING LEAKING AT THE INSERTION. NO IMPACT KNOWN TO THE PATIENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387163 ↗
• MalfunctionNov 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT GRAY LUMEN OF TRIPLE LUMEN PICC WAS LEAKING WHEN THE IV/TRANSFUSION NURSE WAS CALLED TO CHECK THE CATHETER. PICC WAS REMOVED AND THEN CONFIRMED THAT IT WAS THE GRAY LUMEN THAT WAS LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136410 ↗
• MalfunctionNov 13, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT AFTER IT WAS USED AND, IN THE TRAY, THE LAST 3CM OF THE PICC GUIDEWIRE WAS FOUND BROKEN OFF FROM THE REST OF THE WIRE. IT WAS DETERMINED THAT THE COMPLETE GUIDEWIRE WAS REMOVED, AND THE WIRE WAS THEN DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124892 ↗
• MalfunctionJul 12, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED, TRIPLE LUMEN PICC LINE WAS PLACED TODAY AND WHEN REMOVING THE STYLE IT WAS CURLED. ADDITIONAL INFORMATION 5/22/2023: PATIENT WAS NOT COMPROMISED, AND NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313024 ↗
• MalfunctionJun 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER THAT, 2 TRIPLE LUMEN PICC LINES WERE PLACED TODAY AND WHEN REMOVING THE STYLET IN BOTH THE LINES WE PLACED THE STYLET CURLED. ADDITIONAL INFORMATION PROVIDED 22 MAY 2023 IT WAS REPORTED BY THE CUSTOMER "PATIENTS WERE NOT COMPROMISED, AND NO INJURY OCCURRED." THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083529 ↗
• MalfunctionJun 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER THAT, 2 TRIPLE LUMEN PICC LINES WERE PLACED TODAY AND WHEN REMOVING THE STYLET IN BOTH THE LINES WE PLACED THE STYLET CURLED. ADDITIONAL INFORMATION PROVIDED 22 MAY 2023 IT WAS REPORTED BY THE CUSTOMER "PATIENTS WERE NOT COMPROMISED, AND NO INJURY OCCURRED." THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083525 ↗
• InjuryMar 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THEY "HAD AN INCIDENT WITH A PICC LINE ON FRIDAY. THE PICC LINE SOMEHOW BECAME KNOTTED INSIDE THE PATIENT¿S VEIN AND HAD TO BE REMOVED IN CATH LAB." ADDITIONAL INFORMATION RECEIVED: A DETAILED DESCRIPTION OF THE EVENT: PICC LINE BEING PLACED FOR VASOPRESSOR THERAPY. PICC DIDN¿T APPEAR TO BE ¿DROPPING¿ RIGHT, APPEARED TO BE FLIPPING AND CURLING. PULLED WIRE BACK TO RESET SHERLOCK. TRIED TO ADVANCE WIRE BUT COULDN¿T GET THE WIRE IN COMPLETELY, FELT RESISTANCE. UNABLE TO DRAW BLOOD OR FLUSH AS WELL. ATTEMPTED TO PULL THE PICC LINE BACK BUT FELT RESISTANCE WHEN TRYING TO LINE OUT. GOT AN XRAY TO VIEW WHAT WAS HAPPENING WITH THE LINE AND SAW THAT THE LINE WAS KNOTTED INSIDE VESSEL. PHYSICIAN TOOK PATIENT TO CATH LAB TO REMOVE LINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16510658 ↗
• InjurySep 9, 2022Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "INITIAL GUIDEWIRE WAS BEING FED THROUGH THE INTRODUCER NEEDLE INTO A VESSEL IN THE PATIENT'S LEFT UPPER ARM. THERE WAS DIFFICULTY THREADING THE NEEDLE THROUGH THE ARM. WHEN ATTEMPTING TO BACK WIRE OUT OF ARM THERE WAS RESISTANCE FELT AT THE INSERTION SITE OF THE INTRODUCER NEEDLE. WHEN INTRODUCER NEEDLE AND WIRE WERE PULLED FROM THE PATIENT'S ARM, THERE APPEARED TO BE PART OF THE WIRE REMAINING IN PATIENT'S LEFT UPPER ARM. THE THIN REMNANT OF WIRE WAS PULLED FROM THE PATIENT'S ARM. DR. NOTED THE FRAGMENT WAS SMALL ENOUGH THAT IT WOULD BE DIFFICULT TO FIND TO SURGICALLY REMOVE. SO THEY DID NOT DO ANY INTERVENTIONS TO REMOVE. PT. WAS DISCHARGED TO GUARDS WITH NO DOCUMENTED ISSUES IN THE ARM."

  Patient problems: Foreign Body In Patient

  MAUDE report 15396730 ↗
• MalfunctionAug 2, 2022Material Fragmentation; Failure to Advance

  INITIAL GUIDEWIRE WAS BEING FED THROUGH THE INTRODUCER NEEDLE INTO A VESSEL IN THE PATIENT'S LEFT UPPER ARM. THERE WAS DIFFICULTY THREADING THE NEEDLE THROUGH THE ARM. WHEN ATTEMPTING TO BACK WIRE OUT OF ARM THERE WAS RESISTANCE FELT AT THE INSERTION SITE OF THE INTRODUCER NEEDLE. WHEN INTRODUCER NEEDLE AND WIRE WERE PULLED FROM THE PATIENT'S ARM, THERE APPEARED TO BE PART OF THE WIRE REMAINING IN PATIENT'S LEFT UPPER ARM. THE THIN REMNANT OF WIRE WAS PULLED FROM THE PATIENT'S ARM. DR NOTED THE FRAGMENT WAS SMALL ENOUGH THAT IT WOULD BE DIFFICULT TO FIND TO SURGICALLY REMOVE. SO THEY DID NOT DO ANY INTERVENTIONS TO REMOVE. PT WAS DISCHARGED TO GUARDS WITH NO DOCUMENTED ISSUES IN THE ARM. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15156154 ↗
• MalfunctionMay 21, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED "ACCOUNT REPORTS PLACING PICC WITH NO ISSUES. REPORTS USING SHERLOCK 3CG WITH TIP CONFIRMATION, SHOWED "PERFECT 3CG GREEN DIAMOND, NO DEFLECTION AND GOT CHEST XRAY AND THEY WERE DEEP. 4-6 CM TOO DEEP". NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465602 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "OVER THE PAST 3 DAYS WE HAVE HAD 2 PATIENTS WITH DVT DIAGNOSED POST PICC PLACEMENT." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13254568 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "OVER THE PAST 3 DAYS WE HAVE HAD 2 PATIENTS WITH DVT DIAGNOSED POST PICC PLACEMENT." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13254527 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "OVER THE PAST 3 DAYS WE HAVE HAD 3 PATIENTS WITH DVT DIAGNOSED POST PICC PLACEMENT. [ALL] THREE PATIENTS HAD PICCS FROM LOT #REFW2507" NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13253391 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "OVER THE PAST 3 DAYS WE HAVE HAD 3 PATIENTS WITH DVT DIAGNOSED POST PICC PLACEMENT. [ALL] THREE PATIENTS HAD PICCS FROM LOT #REFW2507" NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13253341 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "OVER THE PAST 3 DAYS WE HAVE HAD 3 PATIENTS WITH DVT DIAGNOSED POST PICC PLACEMENT. [ALL] THREE PATIENTS HAD PICCS FROM LOT #REFW2507" NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13253334 ↗
• InjuryJan 6, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "THE POWER PICC SOLO [LEFT] BEHIND A ¿PIECE¿ IN THE PATIENT. I BELIEVE PERHAPS A PIECE OF THE STYLET? ...THEY DID RETRIEVE AND SAVE THE ¿PIECE'."

  Patient problems: Foreign Body In Patient

  MAUDE report 13180584 ↗
• MalfunctionOct 8, 2021Material Frayed; Material Frayed

  IT WAS REPORTED A TRIPLE LUMEN WAS PLACED ON PATIENT. IT WAS STATED THE WIRE WAS CHECKED AND IT PULLED APART VERY EASILY WITH LITTLE EFFORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598163 ↗
• InjuryOct 8, 2021Material Frayed; Material Frayed

  IT WAS REPORTED BY HEALTH PROFESSIONAL "FRIDAY SEPT 10TH, I ATTEMPTED TO PLACE A TRIPLE LUMEN PICC LINE. I ACCESSED THE VEIN EASILY AND THE WIRE ADVANCED FINE AS WELL AS THE INTRODUCER. I HAD SOME DIFFICULTY ADVANCING THE PICC LINE FROM THE BEGINNING, BUT I THEN WAS ABLE TO GET IT TO APPROXIMATELY THE SUBCLAVIAN AREA. IT WOULD NOT GO ANY FURTHER. I DID PULL OUT THE TPS STYLET ABOUT HALFWAY AND THEN RE-ADVANCED IT TO SEE WHERE THE PICC ENDED BY LOOKING AT SHERLOCK. I DID THIS APPROXIMATELY 3-4 TIMES. I THEN LEFT THE CATHETER IN PLACE AND REMOVED THE TPS STYLET. I DID NOT NOTICE THAT ANY OF THE STYLET WIRE WAS MISSING. I KNEW I WAS NOT IN THE SVC, BUT I WASN'T SURE WHERE THE TIP OF THE PICC WAS AT, SO I OBTAINED A CXR. I DIDN'T WANT TO PULL THE PICC AS THE PATIENT WAS A VERY ILL COVID PATIENT WHO WAS CLOSE TO NEEDING INTUBATION. I WAS ABLE TO FLUSH THE CATHETER AND ASPIRATE BLOOD. ON THE CXR I COULD SEE WIRE STICKING OUT OF THE PICC LINE. THE PATIENT THEN HAD TO GO TO IR AND HAVE THE WIRE AND PICC LINE REMOVED."

  Patient problems: Foreign Body In Patient

  MAUDE report 12598161 ↗
• MalfunctionJun 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ¿STYLET WIRE CAME OUT BENT AT ABOUT 1 CM FROM TIP. PICC WAS PLACED SUCCESSFULLY. I DID HAVE TO REPOSITION ARM IN ORDER TO GET THE PICC TO ADVANCE PAST THE AXILLA.¿ ADD INFO RCVD 02/09/2021: PLACEMENT INFO: PLACED IN L BRACHIAL WAS THERE PATIENT HARM REPORTED?: NO. (B)(6) 2021- THE RETURNED WIRE IS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013440 ↗
• MalfunctionJun 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A TRIPLE THAT WAS PLACED TODAY. WHEN SHE PULLED THE STYLET OUT IT WAS KINKED AT A 90 DEGREE ANGLE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971283 ↗