PowerPICC Catheter 3174118Recalls & reported problems

Summary

The FDA's MAUDE database contains 402 adverse event reports that list this exact device (DI 00801741027598), received between Feb 19, 2016 and Sep 24, 2026 — classified as 27 injuries, 375 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (245 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. 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 402 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887523 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874624 ↗
• MalfunctionSep 23, 2026Material Deformation

  It was reported on April 1, 2026, during a PICC replacement procedure, the package of the peripherally inserted central catheter (PICC) was opened and inspected. It was found that the peelable split sheath had a raised/protruding tip. The device was immediately replaced with a new one. No apparent harm occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868115 ↗
• MalfunctionAug 31, 2026Fluid/Blood Leak

  It was reported after two months of use, the patient discovered fluid leakage and broken tubing. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533109 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50454711 ↗
• MalfunctionAug 12, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220513 ↗
• MalfunctionJul 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825222 ↗
• MalfunctionJun 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT HAD A SINGLE LUMEN POWER PICC CATHETER INSERTED ON MAY 9. THE FOLLOWING DAY, EXUDATE WAS OBSERVED NEAR THE PUNCTURE SITE. UPON PULLING THE CATHETER OUT SLIGHTLY, A LONGITUDINAL TEAR NEAR THE 0-MARK WAS DISCOVERED, CAUSING LEAKAGE, SO THE CATHETER WAS REMOVED.

  Patient problems: Fluid Discharge

  MAUDE report 25411059 ↗
• MalfunctionJun 2, 2026Fluid/Blood Leak

  IT WAS REPORTED ON MAY 18, DURING A ROUTINE IV INFUSION, THE PATIENT REPORTED SWELLING IN THEIR ARM AND EXUDATE AT THE PUNCTURE SITE. UPON REMOVAL OF THE CATHETER, A RUPTURE WAS DISCOVERED 5 CM FROM THE TIP. THE CATHETER WAS SUBSEQUENTLY REINSERTED TO MEET THE PATIENT¿S TREATMENT NEEDS. DELAY IN THE PATIENT¿S FOLLOW-UP CHEMOTHERAPY ON THAT DAY. CATHETER SECURED WITH SIROCCO FIXATION. CATHETER WAS REMOVED SMOOTHLY WITHOUT COMPLICATION. A NEW CATHETER PLACED. NO OTHER INTERVENTION NEEDED.

  Patient problems: Erythema; Fluid Discharge; Swelling/ Edema

  MAUDE report 25361766 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE POWER SINGLE-LUMEN CATHETER RUPTURED AND BECAME UNUSABLE, RESULTING IN THE PATIENT HAVING TO BE EXTUBATED AND THE PROCEDURE NEEDING TO BE REPEATED. THE LEAK WAS INTERNAL TO THE PATIENT. THE PATIENT DID NOT HAVE SYMPTOMS OR COMPLICATIONS RELATED TO THE LEAK AND NO INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291820 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  IT WAS REPORTED DURING THE INITIAL CATHETERIZATION PROCEDURE, THE EXTENSION TUBING WAS DAMAGED; UPON PROMPT DETECTION, THE CATHETER WAS REPLACED IN SITU. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164839 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED FOLLOWING A 3-MONTH INDWELLING PERIOD, LEAKAGE AT THE PUNCTURE SITE WAS OBSERVED DURING ROUTINE CATHETER MAINTENANCE IN THE WARD. AFTER EVALUATION, CONTINUED CATHETERIZATION WAS NOT RECOMMENDED. UPON REMOVAL TWO POINTS OF DAMAGE WERE FOUND ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089048 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED A PATIENT WITH A BLOOD DISORDER HAD A CATHETER IN PLACE FOR 2 MONTHS. DURING CATHETER MAINTENANCE IN THE DAY WARD, EXUDATE WAS OBSERVED AT THE PUNCTURE SITE. CONTINUED CATHETERIZATION WAS NOT RECOMMENDED, AND UPON REMOVAL, TWO AREAS OF DAMAGE WERE FOUND. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089045 ↗
• MalfunctionMay 5, 2026Product Quality Problem; Contamination /Decontamination Problem

  IT WAS REPORTED WHITE POWDER ON THE GUIDEWIRE INSIDE THE CATHETER. NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087506 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  IT WAS REPORTED, A BREAKAGE WAS DISCOVERED INSIDE THE CATHETER AFTER A 3-MONTH INDWELLING PERIOD. INCIDENT: ON (B)(6) 2026, THE CATHETER WAS INSERTED IN THE PICC OUTPATIENT CATHETERIZATION ROOM AT THIS HOSPITAL. ON (B)(6) A WARD NURSE PERFORMING CATHETER MAINTENANCE NOTICED BLOOD AND FLUID LEAKAGE AT THE INSERTION SITE. THIS WAS REPORTED TO THE INTRAVENOUS THERAPY TEAM. AFTER EVALUATION, THE INTRAVENOUS THERAPY TEAM RECOMMENDED DISCONTINUING THE CATHETER. UPON REMOVAL, A RUPTURE WAS FOUND 3 CM INSIDE THE CATHETER, WITH 2 CM OF THE CATHETER PROTRUDING EXTERNALLY. AS THE PATIENT REQUIRES FURTHER TREATMENT, A NEW CATHETER (OF A DIFFERENT BRAND) WAS REINSERTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050180 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE PICC LINE WAS SUCCESSFULLY INSERTED UNDER ULTRASOUND GUIDANCE ON (B)(6), 2025. WHILE THE PATIENT WAS GETTING OUT OF BED, SHE SUDDENLY EXPERIENCED SHORTNESS OF BREATH, DIZZINESS, AND CYANOSIS OF THE LIPS. SHE WAS IMMEDIATELY TRANSPORTED TO THE EMERGENCY DEPARTMENT, WHERE HER SYMPTOMS SUBSEQUENTLY SUBSIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; Dyspnea; Hypersensitivity/Allergic reaction

  MAUDE report 25047596 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, TWO INCIDENTS OF ALLERGIC REACTION RESPONSE TO PICC. THIS REPORT ADDRESSES BOTH DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25047575 ↗
• MalfunctionApr 28, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING THE CATHETERIZATION PROCEDURE THAT THE PRINT SCALE WAS MISSING 0-5 CM SCALE MARKINGS; NO CLEANING SOLUTION WAS USED ON THE CATHETER, AND A NEW CATHETER WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019989 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT (B)(6) 2025, THE PATIENT HAD A CATHETER IMPLANTED AT HOSPITAL. THE PATIENT WAS SUBSEQUENTLY DISCHARGED. ON (B)(6) 2026, WHILE RECEIVING INTRAVENOUS THERAPY IN THE DEPARTMENT, FLUID LEAKED FROM THE PUNCTURE SITE DURING THE PRIMING OF THE CATHETER. CONCERNED ABOUT THE RISK OF FLUID LEAKAGE, THE CATHETER WAS REMOVED. UPON EXAMINATION, A FRACTURE IN THE CATHETER WAS DISCOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001579 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT IN OCTOBER 2025, THE PATIENT HAD A CATHETER IMPLANTED. THE PATIENT WAS SUBSEQUENTLY DISCHARGED. ON (B)(6) 2026, WHILE RECEIVING INTRAVENOUS THERAPY, FLUID LEAKED FROM THE PUNCTURE SITE DURING THE PRIMING OF THE CATHETER. CONCERNED ABOUT THE RISK OF FLUID LEAKAGE, THE CATHETER WAS REMOVED. UPON EXAMINATION, A FRACTURE IN THE CATHETER WAS DISCOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971345 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A CATHETER IMPLANTED ON (B)(6) 2025, AND WAS DISCHARGED DURING THAT PERIOD. ON (B)(6) 2026, WHILE RECEIVING INTRAVENOUS THERAPY IN THE DEPARTMENT, FLUID LEAKED FROM THE PUNCTURE SITE DURING THE PRIMING OF THE CATHETER. CONCERNED ABOUT THE RISK OF FLUID LEAKAGE, THE CATHETER WAS REMOVED; UPON EXAMINATION, A FRACTURE HOLE WAS FOUND IN THE CATHETER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866836 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS WITHDRAWN AFTER FLUID LEAKAGE WAS DETECTED; A PERFORATION WAS FOUND 7 CM FROM THE PUNCTURE SITE. ADDITIONAL INFORMATION RECEIVED ON 4/2/2026: THIS INCIDENT RESULTED IN THE INTERRUPTION OF THE PATIENT¿S TREATMENT. LEAKING DURING THE INFUSION CAUSED THE EXACT DOSE OF MEDICATION ADMINISTERED TO THE PATIENT TO BE UNCLEAR. NO ISSUES WERE DETECTED DURING THE EXAMINATION OF THE EXPOSED CATHETER SEGMENT; HOWEVER, UPON CATHETER REMOVAL, A PERFORATION WAS FOUND 7 CM FROM THE INSERTION SITE, THOUGH THE CATHETER HAD NOT COMPLETELY FRACTURED. AFTER REMOVAL, THE PATIENT REFUSED TO HAVE THE PICC REINSERTED AND SWITCHED TO A CVC. NO FURTHER DETAILS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24859862 ↗
• MalfunctionApr 1, 2026Material Frayed

  IT WAS REPORTED THAT WHEN A VENOUS SPECIALIST NURSE IS INSERTING OR REMOVING A PICC LINE, IF, WHILST ADVANCING THE CATHETER INTO THE PATIENT¿S BODY OR WITHDRAWING THE GUIDEWIRE, THEY NOTICE THAT THE GUIDEWIRE HAS BECOME ELASTIC (WHEREAS THE ORIGINAL GUIDEWIRE WAS NOT ELASTIC), AND WITHDRAWAL IS OBSTRUCTED, THE GUIDEWIRE STRETCHES AND BECOMES THINNER; IN SUCH CASES, THE HEPARIN CAP SHOULD BE REMOVED BEFORE WITHDRAWING THE GUIDEWIRE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755973 ↗
• MalfunctionMar 17, 2026Failure to Infuse; Material Deformation

  IT WAS REPORTED THAT PICC KIT NEEDLE FREE CONNECTOR WOULD NOT FLUSH AFTER 12 HOURS - FRESH PLACEMENT AND ONLY THING RUNNING THROUGH THE PICC WAS SALINE. CUSTOMER DESCRIBED THE CONNECTOR LIKE IT WAS CONCRETE. PATIENT NEEDED A NEW PICC - HAD TO DO UNNECESSARY RESTART AS THE CAP WAS STUCK TO THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622359 ↗
• MalfunctionMar 3, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER THAT THE STYLET IS EXCESSIVELY LONG, AND THE TIP IS NOT SHEATHED. NO FURTHER INFORMATION CAN BE PROVIDED BY CUSTOMER. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES. 02/19/2026: IT WAS FOUND DURING AN INVESTIGATION THE OUTER COIL WIRE BECAME UNRAVELED, AND THE DISTAL TIP OF THE STYLET WAS OBSERVED TO BE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495795 ↗