PowerPICC® Catheters 1174108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 222 adverse event reports that list this exact device (DI 00801741034459), received between Nov 3, 2015 and May 13, 2026 — classified as 9 injuries, 213 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (107 reports).

1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 11, 2025Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 222 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT IRREGULAR EDGE ON DILATOR IN PICC KIT THAT WILL NOT PUSH THROUGH THE VEIN. HAD TO PULL NEW DILATOR AND FINISHED THE LINE - UNKNOWN IF ANY DAMAGE DONE TO THE VESSEL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164097 ↗
• MalfunctionFeb 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT 4FR DL SV WITH A HOLE. THE HOLE IS RIGHT BELOW THE HUB. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235310 ↗
• MalfunctionNov 25, 2025Material Frayed; Material Twisted/Bent; Material Frayed; Material Twisted/Bent

  IT WAS REPORTED GUIDEWIRE NOTED TO BE DIFFICULT TO REMOVE AND REPLACE IN LINE PRIOR TO PLACEMENT IN PATIENT.  UPON REMOVAL, GUIDEWIRE CURLED LIKE A RIBBON AND MADE THE LINE UNUSABLE. PATIENT'S SKIN WAS SHREDDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Abrasion

  MAUDE report 23646606 ↗
• MalfunctionNov 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION: WE WERE NOT INFORMED OF ANY LEAKAGE THAT OCCURRED PRIOR TO THE INCIDENT OF ATTEMPTED REMOVAL. THE PATIENT WAS ON DAPTOMYCIN 450MG ONCE DAILY INFUSED OVER 30MIN, ZOSYN 3.375GM Q8HR INFUSED OVER 4H, AND NS AT 100ML/HR CONTINUOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645915 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PICC BROKE. PATIENT WAS WHEELING HER WHEELCHAIR AND HEARD SOMETHING HIT THE FLOOR...IT WAS THE TOP OF HER PICC. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714557 ↗
• MalfunctionJul 14, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT SAFETY NEEDLE MALFUNCTION, GREEN CAP CAME COMPLETELY OFF THE END. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500360 ↗
• MalfunctionJul 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER DURING SINGLE LUMEN 4FR PICC INSERTION, RESISTANCE MET BUT ABLE TO FULLY PASS CATHETER. MULTIPLE PASSES MADE WITH PATIENT PERFORMING VAGAL MANEUVERS AND POSITION CHANGES AS PICC WOULD NOT DROP. WHEN 3CG WIRE WAS REMOVED FROM CATHETER AND INSPECTED, KINK NOTED AND CATHETER INTEGRITY APPEARED TO BE COMPROMISED. THIS WIRE WAS IMMEDIATELY REMOVED FROM THE PROCEDURE AND A NEW KIT WAS USED FOR THE REST OF THE PROCEDURE AND TIP OF CATHETER WAS PRESENT UPON INSPECTION. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468119 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC LINE HAS A HOLE AND LEAKS AT THE 5CM MARK. PATIENT NEEDED NEW LINE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378954 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 4FR SINGLE LUMEN PICC FRACTURED. THE TEAR WAS BETWEEN THE 2CM AND 3CM MARK WITH ZERO BEING TRUE ZERO. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196114 ↗
• InjuryMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED; LEAKING LINE OCCURRED OVER THE WEEKEND. THE EXTERNAL LENGTH OF THE LINE HAD A FRACTURE/HOLE AND WAS CONTINUOUSLY LEAKING (A MORPHINE DRIP WAS RUNNING). NURSING STAFF HAS ¿PLUGGED¿ THE HOLE BY WRAPPING A TEGADERM AROUND IT. THE NEGATIVE OUTCOME FOR THIS INCIDENT WAS THE DELAY IN CARE. PATIENT¿S CONTINUOUS MORPHINE DRIP HAD TO BE HELD FROM THE TIME THE LINE WAS REMOVED UNTIL THE NEW LINE WAS INSERTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071723 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE PICC EXTERNAL TUBING WAS FOUND TO BE LEAKING ON MONDAY (B)(6) 2025; A HOLE/CRACK WAS PRESENT. A MORPHINE DRIP WAS RUNNING. THE NURSING STAFF "PLUGGED" THE HOLE BY WRAPPING A TEGADERM AROUND IT (NURSING STAFF HAS SINCE BEEN EDUCATED). THERE WAS NO HARM TO THE PATIENT, BUT A NEW PICC HAD TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063410 ↗
• MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED 4F SL PICC WITH HOLE - "PATIENT HAD PICC PLACED ON 3/20 (LOT #REJW2363). DISCHARGED FROM HOSPITAL THEN CAME BACK FOR TROUBLESHOOTING (NOT DRAWING BACK/HARD TO FLUSH). CHEST X-RAY SHOWED IT WAS IN APPROPRIATE POSITION BUT WE HAD TO REPLACE D/T MALFUNCTION. AFTER REMOVAL, TEAM ASSESSED AND NOTICED FLUSH WAS EXITING THRU HOLE/CUT BETWEEN 5-6 CM MARKS." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030783 ↗
• MalfunctionApr 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THEY REMOVED A PICC LINE FROM A PATIENT TODAY (IT WAS PLACED ON (B)(6) 2025. THE EXPOSED CATHETER HAD A FRACTURE/HOLE AND WAS LEAKING. THE PATIENT STATES THERE WAS NO UNUSUAL ACTIVITY ON HIS BEHALF AND HE DID NOT SEE ANY STAFF USING ANY SHARP INSTRUMENTS NEAR THE LINE. I¿M NOT SURE IF THIS WAS AN ISSUE WITH THE PRODUCT ITSELF. THE PICC WAS REMOVED DUE TO THE ISSUE WITH LEAKING. IT WAS NOTICED DURING ROUTINE FLUSHING OF THE LINE. THE LEAK WAS IN THE EXTERNAL LINE, AT ABOUT THE 1 CM MARK. THERE WERE 5 CM EXTERNAL UPON PLACEMENT AND THE LINE WAS IN PLACE FOR 30 DAYS BEFORE THE LEAK WAS REPORTED. THERE WAS NOTHING CONTINUOUSLY INFUSING AT THE TIME OF THE REPORTED LEAK. THE PATIENT WAS ON ABX THERAPY. THE EVENT DID NOT CAUSE A DELAY IN TREATMENT AS A NEW PIV WAS PLACED WHEN THE LINE WAS REMOVED. THE PATIENT RECEIVED THEIR REMAINING ABX THROUGH PERIPHERAL IVS. THERE WERE NO OTHER SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE LEAK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940144 ↗
• MalfunctionApr 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED WHEN PLACING A PICC LINE YESTERDAY I HAD THE ECHOGENIC NEEDLE WITHIN THE KIT MALFUNCTION. WHILE REMOVING THE NEEDLE FROM THE SKIN THERE IS A SAFETY MECHANISM THAT IS NORMALLY ABLE TO BE ACTIVATED AS YOU WITHDRAW THE NEEDLE FROM THE SKIN SO THAT YOU ARE NEVER EXPOSED TO A CONTAMINATED SHARP. AS I WAS WITHDRAWING THE NEEDLE OVER THE GUIDEWIRE POST PLACEMENT, I ATTEMPTED TO ACTIVATE THE SAFETY MECHANISM AND IT DETACHED COMPLETELY FROM THE END OF THE CONTAMINATED NEEDLE. I WAS ABLE TO PLACE THE CONTAMINATED SHARP UNDER THE KIT IN MY STERILE FIELD UNTIL THE PROCEDURE WAS COMPLETED AND THEN PLACE IT SAFELY IN A SHARPS CONTAINER. NO PATIENT OR CLINICIAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21779515 ↗
• MalfunctionMar 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THE INTRODUCER COLLAPSED ON ITSELF WHEN TRYING TO ADVANCE, ALMOST LIKE A MUSHROOM SHAPE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700604 ↗
• MalfunctionMar 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THEY PLACED A SINGLE LUMEN PICC ON (B)(6) (LOT #REJW2342) THAT KINKED/LOOPED JUST BEYOND THE INSERTION SITE, WHICH WE DETERMINED ON UE XRS TODAY WHILE TROUBLESHOOTING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653553 ↗
• MalfunctionMar 20, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED ON MARCH 26, 2025: LINE DID NOT WORK (UNABLE TO USE FOR BLOOD DRAWS, TPA GIVEN), REQUIRED REMOVAL AND REPLACEMENT. NO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653328 ↗
• MalfunctionFeb 19, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THAT THE INSIDE OVER FOR THE TRAY WAS RIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411502 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE PATIENT PAIN IN UPPER ARM WITH ALL APPROPRIATE STUDIES SHOWING DONE AND NORMAL. WHILE REMOVING THE OLD PICC A HOLE WAS DISCOVERED AT APPROXIMATELY 3 CM. THE PICC WAS REPLACED. NO OTHER INFORMATION WAS PROVIDED AND NO PATIENT HARM REPORTED.

  Patient problems: Pain

  MAUDE report 21407817 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC WAS PLACED (B)(6) 2024 AND DISCONTINUED ON (B)(6) 2024 AFTER THE PATIENT COMPLAINED OF MODERATE PAIN DURING FLUSHING AND INFUSIONS. ALSO COMPLAINED OF LEAKING OF FLUIDS AT INSERTION SITE. WHEN REMOVED THE LINE WAS FOUND TO HAVE 2 BREAKS TO THE PICC LINE. THEY APPEARED TO BE HORIZONTAL BREAKS LOCATED AT THE 11 AND 13CM MARKS. TEMPORARY PAIN AND MILD SWELLING TO UPPER ARM IN REGARDS TO IVF INFILTRATION. NO PERMANENT DAMAGE DISCOVERED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21328921 ↗
• MalfunctionJan 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, PICC KINKED. PLACED (B)(6) 2024 IN THE MIDDLE 1/3 OF RUE, BASILIC VEIN. CATHETER TRIMMED 45CM, EXTERNAL LENGTH 1CM, BREAK AT 6CM, SECURED WITH AT STATLOCK, PICC WAS NOT TPA'D, AND DWELLED FOR 9 DAYS. PICC EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265297 ↗
• MalfunctionJan 23, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THE GREEN ACCESS NEEDLE PLASTIC BROKE AT THE TOP. THIS HAPPENED AS THE CLINICIAN WAS INSERTING THE NEEDLE INTO THE PATIENT. THE END USER WAS SUCCESSFUL WITH PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219757 ↗
• MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT RN STATES PICC IS LEAKING. UPON ASSESSMENT PICC WOULD NOT FLUSH EASILY, AND WHEN I TRIED TO DRAW BLOOD, AIR CAME INTO SYRINGE. I IMMEDIATELY REMOVED THE DRESSING AND UPON FLUSHING I SAW A STREAM OF FLUID COMING FROM THE PLACE IN THE IMAGE. ITS NOT A SLIT, BUT A PINHOLE. I DC ED PICC INTACT AND PLANNING ON PLACING NEW PICC LATER TODAY. NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488087 ↗
• MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, ENCOUNTERED AN ISSUE WITH A BARD PICC LEAKING WHEN FLUSHED. IT WAS INDEED LEAKING. WHEN D/C¿ING THE PICC I FOUND THAT IT WAS PARTIALLY SEVERED AT APPROXIMATELY THE 5CM MARK. TO COMPLICATE MATTERS, I WAS NOT ABLE TO FULLY D/C THE PICC. I WAS ONLY ABLE TO REMOVE IT HALF WAY. MET LOTS OF RESISTANCE. TRIED A FEW DIFFERENT TECHNIQUES WITHOUT SUCCESS. THE FACILITY WAS GOOD TO SEND THE PATIENT TO THE HOSPITAL FOR FURTHER EVALUATION. PICC PLACED 07/05/2024 IN THE RIGHT BRACHIAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164232 ↗
• MalfunctionJul 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE PICC 3CG WIRE WAS BENT. MISSED STICK ATTEMPT AND DISCOMFORT DURING STICK. NO OTHER INFORMATION WAS PROVIDED. 07/03/2024 - THE DEVICE RETURNED FOR EVALUATION WAS KINKED ON THE STYLET.

  Patient problems: Discomfort

  MAUDE report 19826700 ↗