PowerPICC SOLO 1194108D5Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00801741155192), received between Dec 14, 2018 and Apr 24, 2026 — classified as 6 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (36 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Mar 11, 2025Class IOpen, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Unsealed Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THAT MOISTURE/LIQUID FOUND INSIDE STERILE PICC KIT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981775 ↗
• MalfunctionJan 13, 2026Fluid/Blood Leak

  IT WAS REPORTED, PATIENT WITH A 4FR SINGLE LUMEN PICC LINE WHICH HAS A SMALL HOLE JUST ABOVE 6CM. LINE WAS PLACED (B)(6) 2026. PATIENT STATED OVER LAST COUPLE OF WEEKS LINE WOULD BE DIFFICULTY TO FLUSH OR NOT HAVE BLOOD RETURN AND SON WOULD HAVE TO PUSH HARD WHILE FLUSHING TO GET IT TO WORK. YESTERDAY UNABLE TO FLUSH LINE SO WENT TO ER. THEY TRIED TWO DOSES OF CATHFLO WHICH DID NOT RESOLVE ISSUE. PATIENT STATES BOTH THE NURSE AND SON ATTEMPTED TO FLUSH LINE WHILE PUSHING HARD. WHEN PATIENT PRESENTED TO OUR ER, I CHANGED INJECTION CAPS AND DRESSING. NO KINKING OR OTHER ISSUE NOTED AND LINE UNABLE TO FLUSH. CXR OBTAINED AND TIP CURLED IN MID-SVC. ER PHYSICIAN RECOMMENDED RETRACTING 4CM AND WHILE RETRACTING NOTICED CLEAR FLUID LEAKING FROM SITE. I ATTEMPTED TO FLUSH AND BLOODY FLUID LEAKING FROM SITE. I REMOVED LINE AND NOTED SM HOLE JUST ABOVE 6CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054907 ↗
• InjuryDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC LINE THAT WAS REMOVED DUE TO A LARGE AMOUNT OF LEAKING AT THE SITE WITH FLUSHING/INFUSING. THE PATIENT WAS + FOR DVT IN THE ARM, BUT THERE WAS ALSO CONCERN THAT THE SINGLE LUMEN PICC LINE CATHETER HAD A CRACK IN IT, GIVEN THE AMOUNT OF FLUIDS COMING FROM THE INSERTION SITE WITH FLUSHING. THE PATIENT HAD A LARGE INFILTRATION OF THE ARM, THE SWELLING OF THE ARM IS WHAT PROMPTED THE NURSING STAFF TO CALL IV TEAM FOR ASSESSMENT. NO SIGNIFICANT INJURY, SWELLING DECREASED OVER 24 HOURS AFTER LINE WAS REMOVED.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 23820446 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION: STATLOCK WAS USED TO SECURE THE DEVICE. NO TREATMENT NEEDED.

  Patient problems: Erythema; Extravasation; Pain

  MAUDE report 23705753 ↗
• MalfunctionNov 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN OUTPATIENT TODAY WITH 4FR SINGLE LUMEN PICC LINE THAT HAS A SMALL SLIT IN IT AT 12CM. PT'S WIFE IS AN RN. YESTERDAY, SHE STATED THAT DRESSING WAS WET AND PT FELT LIKE THE LINE WAS LEAKING. SHE REMOVED THE DRESSING AND FLUSHED IT W/O PROBLEMS. TODAY PT WITH COMPLAINT OF PAIN WITH FLUSHING AND WAS LEAKING AT SITE WITH FLUSHING. WHEN PT PRESENTED TO INFUSION CLINIC, THE DRESSING WAS WET BUT PT HAD JUST TAKEN A SHOWER. LINE FLUSHED EASILY WITH BRISK BLOOD RETURN HOWEVER SITE WAS LEAKING WITH FLUSHING. LINE REMOVED W/O DIFFICULTY AND NOTICED SMALL SLIT AT 12CM. LINE PLACED (B)(6) 2025. LINE TRIMMED AT 50CM AND HAD 6CM OUT WITH SECURACATH INTACT.

  Patient problems: Pain

  MAUDE report 23632981 ↗
• MalfunctionSep 17, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED CUSTOMER ENCOUNTERED HAIR IN A PICC KIT. THIS WAS NOTICED RIGHT AWAY AND ANOTHER PICC KIT WAS USED SO THERE WAS NO PATIENT HARM. THE NURSES WHO WERE PRESENT AT THE TIME THE KIT WAS OPENED HAD HAIR NETS ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076329 ↗
• MalfunctionAug 26, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED A HAIR WAS FOUND INSIDE A STERILE KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900885 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH LEAKING PERIPHERAL INSERTED CENTRAL CATHETER. THERE WAS NOT A SERIOUS INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669427 ↗
• MalfunctionJun 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC HAD BEEN IN USE WITHOUT ISSUE FOR APPROXIMATELY 1 MONTH BEFORE IT BEGAN LEAKING. THIS PROMPTED THE PATIENT TO RETURN TO THE EMERGENCY DEPARTMENT FOR EVALUATION AND REMOVAL OF THE CATHETER. UPON INSPECTION, WE NOTED A DEFECT IN THE CATHETER MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179596 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT WHEN A PATIENT WAS BEING DISCONNECTED FROM IV SALINE TUBING IT WAS ASSESSED THAT THERE WAS SALINE COMING OUT FROM UNDER HIS DRESSING. I HAD JUST PERFORMED A DRESSING CHANGE AT THE BEGINNING OF HIS 1L NS INFUSION. I FLUSHED THE LINE VIGOROUSLY WITH 10ML IV PUSHES. I OBSERVED THAT SALINE WAS GATHERING UNDERNEATH THE DRESSING. I REMOVED THE DRESSING. THE SALINE WAS TUNNELING OUT FROM INSERTION SITE. I OBSERVED THAT A SMALL AMOUNT OF SALINE HAD EXTRAVASATED INTO TISSUE AS EVIDENCED BY SWELLING AT PICC INSERTION SITE. I INFORMED THE PATIENT THAT THE LINE WOULD HAVE TO BE REMOVED. THE LINE WAS PLACED AT 4 CM OUT AND WAS STILL AT 4 CM OUT AT TIME OF LEAK BEING DISCOVERED. IT DID HAVE CHEMO GIVEN THROUGH IT SEVERAL WEEKS AGO, DURING THIS INFUSION THE PATIENT JUST RECEIVED SALINE. ANOTHER CENTRAL LINE HAD TO BE PLACED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Infiltration into Tissue; Swelling/ Edema

  MAUDE report 22064230 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT PICC WAS LEAKING/CRACKED AT 0CM AND WAS NOT USABLE FOR TREATMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019312 ↗
• MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A LEAKING PICC LINE THAT WAS PLACED ON (B)(6) 2025. UPON FURTHER ASSESSMENT, THE NURSE DISCOVERED A CRACK IN THE CATHETER, LOCATED 5 CM FROM THE EXTERNAL INSERTION SITE, WHEN REMOVING IT. THE PICC LINE WAS PLACED ON (B)(6) 2025 AND FOUND FRACTURE ON (B)(6) 2025. NO SERIOUS ADVERSE EVENT OBSERVED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887238 ↗
• MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, SMALL FRACTURE. LINE WAS PLACED ON (B)(6) 2025 TRIMMED 44 CM, OUT 2CM AND SECURED WITH A SECURACATH. LINE WAS FRACTURED AT 3CM. PATIENT REPORTED PAIN WITH FLUSHING SINCE SUNDAY AND NO BLOOD RETURN NOTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 21691576 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER; THEY HAD A PATIENT COME BACK IN WITH A PICC LEAKING. THEY ENDED UP PULLING IT AND FOUND A HOLE A AT THE 6CM MARK. PATIENT HAD THE PICC SINCE DECEMBER 6TH. PATIENT HAD TO BE STUCK AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318997 ↗
• MalfunctionJan 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC LINE LEAKING NEAR THE INSERTION SITE. S/L PICC LINE PLACED (B)(6) 2024 IN OUR OUTPATIENT CLINIC, THE EXTERNAL LENGTH WAS 3CM AND A SECUR-A-CATH WAS USED FOR SECUREMENT. PATIENT RECEIVING LONG TERM ANTIBIOTICS (DAPTOMYCIN) FOR POST-OP SPINE SURGERY. NO PATIENT HARM, INJURY, OR COMPLICATION; NO NEGATIVE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283436 ↗
• MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  RN REPORTED THE FOLLOWING: LINE WAS PLACED ON (B)(6) 2024. RN CHARTED THE 6 CM EXTERNAL WAS LEFT OUT. SECURACATH WAS USED FOR SECUREMENT. PATIENT WAS GETTING OUT PATIENT INFUSION DONE AND HIS WIFE WAS FLUSHING THE LINE AT HOME. DRESSING CHANGES WERE ALSO DONE AT THE FACILITIES' INFUSION CLINIC. THE PATIENTS LAST ABX TREATMENT WAS 2 WEEKS AGO, SO THE LINE WAS JUST GETTING FLUSHED DAILY. TODAY, THE PATIENT RETURNED TO THE CLINIC REPORTING THAT FOR THE LAST FEW DAYS THEY HAVE NOTICED LEAKING UNDER THE DRESSING. NO LEAKING WAS NOTED DURING ABX TREATMENTS AT THE INFUSION CLINIC. WHEN THE INFUSION STAFF ASSESSED THE SITE, THEY NOTICED 5 CM EXTERNAL AND THAT LEAKING WAS CONFIRMED AFTER FLUSHING. THE LINE WAS REMOVED DUE TO THE PATIENT NOT NEEDING THE PICC ANYMORE. STAFF REPORTED A FRACTURE AT THE 2 CM MARK. STAFF ALSO NOTED THAT THE SECURACATH WAS CLAMPED AND IN PLACE PROXIMAL TO THE FRACTURE/HOLE. NO HARM TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21212306 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 4FR SINGLE PICC LINE HAD A CRACK IN IT. THEY REMOVED IT FROM THE PATIENT. THERE WAS NO IMPACT TO THE PATIENT. WHEN EVALUATING THE PICC WE NOTICED THAT IT WAS LEAKING AT THE INSERTION SITE AND HAD A VERY SMALL AREA OF SWELLING JUST ABOVE THE INSERTION SITE. THE BREAK WAS SUBCUTANEOUS. WHEN THE PICC WAS DISCONTINUED, A SLIT WAS OBSERVED AT THE 5 CM MARK FROM THE CATHETER HUB. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Swelling/ Edema

  MAUDE report 20879961 ↗
• MalfunctionNov 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT LEAKING CT SCAN IV CONTRAST. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766620 ↗
• MalfunctionNov 13, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY CUSTOMER THAT THE POWERPICC SOLO CATHETER MALFUNCTIONED AFTER REMOVING THE MAGNETIC WIRE, THE PICC COULD NO LONGER ASPIRATE OR BE FLUSHED AND THE CUSTOMER HAD TO OPEN A NEW KIT. NO PATIENT HARM WAS REPORTED DUE TO THE RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673020 ↗
• InjuryOct 30, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY MEDWATCH THAT VASCULAR ACCESS STAFF INSERTED NEW PICC (PERCUTANEOUSLY INSERTED CENTRAL CATHETER), WITHOUT DIFFICULTY, POST INSERTION CHEST X-RAY- SHOWED A METALLIC FOREIGN BODY PROJECTING OVER THE LOWER RIGHT HEART, PROVIDER WAS NOTIFIED OF RESULTS. PATIENT PROCEEDED TO IR WHERE THE FOREIGN BODY WAS SUCCESSFULLY REMOVED. FOREIGN BODY APPEARED THE END OF THE INTERNAL GUIDE WIRE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20568883 ↗
• MalfunctionSep 20, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT BEGINNING INSERTING THE NEEDLE TO ACCESS THE VEIN, PASSED THE GUIDEWIRE THROUGH THE NEEDLE, AND THEN PROCEED TO WITHDRAW THE NEEDLE. IT WAS AT THAT TIME NOTICED THE GREEN SAFETY LOCK ON THE NEEDLE SLIDE RIGHT OFF THE NEEDLE AND ONTO THE WIRE. AT NO POINT DID I FEEL ANY RESISTANCE IN THE SAFETY MECHANISM OR FEEL ANYTHING SNAP, IT JUST CAME RIGHT OFF THE NEEDLE. I CAREFULLY WITHDREW THE NEEDLE AND THE GREEN SAFETY LOCK OFF THE GUIDELINE AND PLACED IT ON MY TRAY UNTIL WE WERE FINISHED AND COULD SAFELY DISPOSE OF IT IN THE SHARPS-CONTAINER. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269138 ↗
• MalfunctionSep 20, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE SAFETY PIECE OF THE NEEDLE FELL OFF DURING PICC INSERTION. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268103 ↗
• MalfunctionAug 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED A CALL MED CENTER PICC NURSE STATING, PICC WAS PLACED ON (B)(6)2024 BY PICC RN. PATIENT WAS DISCHARGED HOME ON (B)(6) WITH PICC IN PLACE. PATIENT WAS RECEIVING HOME ABX AND DRESSING CHANGES. PATIENT RETURNED BACK TO THE FACILITY ON (B)(6)2024 WITH REPORTED ISSUES WITH PICC. RN ASSESSED THE LINE AT THAT TIME AND REPORTED CATHFLO WAS GIVEN AND THAT THE PICC WAS POSITIONAL AT TIMES BUT WORKING. THIS WAS REPORTED A FEW OTHER TIMES AND CATHFLO WAS GIVEN BY OUTPATIENT INFUSION. PATIENT RECEIVED THE LAST ABX TREATMENT ON (B)(6) BUT WAS INSTRUCTED TO KEEP PICC IN UNTIL (B)(6). PATIENT CAME INTO THE OUTPATIENT INFUSION CENTER AND RN WAS CALLED ABOUT THE PICC LEAKING. NURSE ASSESSED THE SITE AND NOTED LEAKING. PICC WAS REMOVED AND AT THE 10.5CM MARK A HOLE WAS NOTED. PRIOR XRAY WAS DONE BEFORE THE REMOVAL OF THE PICC AND IT WAS REPORTED BY THE ACCOUNT THAT THERE WAS A KINKED NOTED ON THE PICC PER XRAY IMAGING AROUND THE 10CM MARK. EXTERNAL CM REPORTED WAS 7CM. SECUREMENT USED WAS SECURACATH. NO IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092934 ↗
• MalfunctionAug 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENTS PREVIOUS PICC WAS HAVING ISSUES AND NEEDED TO BE REPLACED. RN, PLACED THE NEW LINE (B)(6) 2024. PICC TEAM WAS NOTIFIED ON MONDAY 8/ 5 FROM THE LOCAL DOCTORS OFFICE STATING THERE WAS NO BLOOD RETURN AND THEY WERE UNABLE TO GET LABS BUT THEY DID A XRAY TO CONFIRM PLACEMENT AND THE TIP OF THE PICC WAS IN THE RIGHT PLACE. PATIENT RETURNED BACK TO THE FACILITY ON 8/7 AND PICC TEAM CONFIRMED NO PLACEMENT SO A REPEAT XRAY WAS DONE AND IT SHOWED A KINK IN TWO PLACES (KINK WAS AROUND THE 2CM AND 6-7CM. RN THEN WENT TO ASSESS THE SITE, AND WHEN THE DRESSING WAS REMOVED THE PICC LINE DISLODGED OUT (REPORTED ABOUT 2 CM CAME OUT). WHEN THEY WENT TO FLUSH THE LINE, SALINE WAS LEAKING OUT OF THE INSERTION POINT. PICC WAS THEN REMOVED AND A FRACTURE WAS NOTED AROUND THE 2CM AND 6CM MARK. WAS TOLD THAT WHEN THE 7/10 PICC WAS PLACED, THE PATIENT WENT FROM BEING WEEKS OF BED BOUND TO AMBULATORY WITH 24-7 WALKER ASSISTANCE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091325 ↗
• MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PICC WAS REMOVED AND MULTIPLE BREAKS WERE FOUND. PICC HAD TO BE REMOVED PRIOR TO COMPLETION OF THERAPY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824526 ↗