PowerPICC Catheter 3174355Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741027635), received between Sep 15, 2017 and Nov 26, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC LINE FOUND TO BE CRACKED/BROKEN AT 1640. APPLIANCE VISIBLY INTACT. BLEEDING FROM TUBING BETWEEN SUTURED HUB AND AUTOCLAVE HUB. SUTURES INTACT; DRESSING INTACT. INFUSION STOPPED. LINE CLAMPED WITH KELLY CLAMP (AS WELL AS OWN CLAMP) AND CLEANED WITH CHLORHEXIDINE STICK. ATTEMPTED TO WITHDRAW FROM LINE BUT ONLY AIR RETURN. NO ATTEMPT WAS MADE TO FLUSH LINE BECAUSE OF THIS. COVERED WITH STERILE GAUZE. CLAMP, LINE THEN WRAPPED TIGHTLY WITH CLOBAM TO SECURE FROM PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655788 ↗
• MalfunctionOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PICC LINE HAD BLOWN OUT. PICC LINE WAS REMOVED FROM PATIENT BECAUSE IT WAS GIVING THEM ISSUES WITH FLUSHING AND BLOOD RETURN. NO ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358356 ↗
• MalfunctionJan 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A PICC FOUND TO HAVE A SMALL FRACTURE WHERE MEDICATION WAS LEAKING OUT OF. IT WAS A DOUBLE LUMEN AND THE FRACTURE IS NAKED TO THE EYE BUT WHEN FLUSHED IT SQUIRTS OUT. SOMEWHERE ON THE SEAM WHERE THE HARD PURPLE DISTAL CONNECTOR PORT MEETS THE FLEXIBLE, SEE THROUGH, CATHETER WINDOW. DOESN'T APPEAR TO HAVE CAUSED ANY PATIENT ISSUES AT THE MOMENT BUT WANTED TO LET YOU KNOW. WE REMOVED THE PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225753 ↗
• MalfunctionAug 29, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE PICC PEEL AWAY THE SHEATH IN A 4FR SINGLE LUMEN POWER PICC DID NOT CRACK AT THE VALVE. DR. CUT THE VALVE CAREFULLY WITH SCISSORS. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20095308 ↗
• MalfunctionApr 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "PICC WAS PLACED IN IR ON 3/4 THE PATIENT WAS DC¿D AND WENT TO A DIFFERENT FACILITY LATER BECAUSE THE CATHETER WAS NOT FLUSHING. THE PATIENT REPORTS A MEDALLION SYRINGE WAS USED TO POWER FLUSH IT, AND AFTER THAT SHE BEGIN HAVING PAIN IN HER ARM FROM INFUSIONS. THEN SHE CAME BACK TO US, THAT PICC LINE WAS REMOVED DUE TO FRACTURE AND ANOTHER PICC LINE WAS PUT IN IN IR. NO PATIENT HARM."

  Patient problems: Pain

  MAUDE report 19134241 ↗
• MalfunctionMar 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE CUSTOMER REMOVED A PICC LINE FROM A PATIENT AND THE LINE HAD A HOLE IN IT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961576 ↗
• MalfunctionJan 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT REGISTERED NURSE (RN) FLUSHING PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WITH 10ML SYRINGE. LINE LEAKING AT INSERTION SITE WITH FLUSHING. LINE WAS REMOVED. ADDITIONAL INFORMATION RECEIVED 12/28/2023: CENTRAL LINE LEAKING FLUIDS UNDER DRESSING, A NEW CENTRAL LINE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484770 ↗
• MalfunctionJul 24, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER INTRODUCER WITH MALFORMATION ON GRAY MAKING IT INOPERABLE. LONG TERM ANTIBIOTICS SO PICC LINE NEEDED. SKIN KNICK GIVEN BEFORE INTRODUCER WAS ATTEMPTED AND IT WOULD NOT PASS OVER THE WIRE AS THERE WAS A MALFORMATION OF THE PLASTIC. ADDITIONAL INFORMATION RECEIVED 13 JULY, 2023: IT WAS STATED THE INTRODUCER WOULDN¿T THREAD INTO PATIENT BECAUSE OF THE BURR ON THE END OF IT. THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. THE ATTEMPTS MADE TO THREAD INTRODUCER FAILED AND TRAUMA IN TRYING TO USE IT AS WE NORMALLY WOULD MAY HAVE CAUSED SOME DAMAGE AND I¿M SURE INCREASED THE RISK OF DVT. WE WERE ABLE TO DROP A INTRODUCER KIT ONTO STERILE FIELD AND USE A NEW INTRODUCER WHICH THREAD EASILY INTO PATIENT AND ALLOWED US TO FINISH HIS PICC LINE INSERTION AT BEDSIDE. THE EVENT DID NOT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT. EVENT OCCURRED ONCE DURING PLACEMENT OF PICC LINE.

  Patient problems: Perforation of Vessels

  MAUDE report 17385547 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FACILITY THAT THE PATIENT HAD A POWERPICC PLACED AND HAD "SOME SORT OF ALLERGIC REACTION". THE PICC WAS REMOVED AND A GROSHONG CVC WAS PLACED. IT WAS REPORTED THAT CHLORAPREP WAS USED BEFORE AND AFTER BOTH INSERTIONS. THIS FILE ADDRESSES THE REACTION TO THE SECOND PICC PLACEMENT. ON (B)(6) 2018 - ADDITIONAL INFORMATION REPORTED BY THE FACILITY, THIS IS THE SECOND OCCURRENCE WHERE THE PICC HAS CAUSED HER TO HAVE AN ALLERGIC REACTION. PICC WAS PLACED ON (B)(6) 2017. TWO WEEKS AFTER PLACEMENT THE PATIENT DEVELOPED A RASH. PICC WAS REMOVED AND A GROSHONG CVC WAS PLACED ON (B)(6) 2018.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 7301602 ↗
• InjuryFeb 27, 2018Component Falling; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE FACILITY THAT THE PATIENT HAD A POWERPICC PLACED AND HAD "SOME SORT OF ALLERGIC REACTION". THE PICC WAS REMOVED AND A GROSHONG CVC WAS PLACED. IT WAS REPORTED THAT CHLORAPREP WAS USED BEFORE AND AFTER BOTH INSERTIONS. THIS FILE ADDRESSES THE REACTION TO THE INITIAL PICC PLACEMENT. ON (B)(6) 2018 - ADDITIONAL INFORMATION REPORTED BY THE FACILITY. PICC WAS PLACED ON (B)(6) 2017. THE FIRST WEEK IN (B)(6) SHE BECAME ITCHY AND HAD HIVES ON HER CHEST AT THE INSERTION SITE AND CONTINUED DOWN HER ARM WHERE THE PICC ENDED. THE PICC FELL OUT DUE TO EXCESSIVE SCRATCHING WHILE THE PATIENT SLEPT. PATIENT WAS GIVEN IV ANTIBIOTICS FOR TWO WEEKS FOR THE RASH. A NEW PICC WAS PLACED ON (B)(6) 2017. TWO WEEKS AFTER PLACEMENT THE PATIENT DEVELOPED A RASH ON THE OTHER SIDE WITH THE SECOND PICC.

  Patient problems: Itching Sensation; Rash; Urticaria

  MAUDE report 7301600 ↗
• MalfunctionDec 19, 2017Crack

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POWERPICC PLACED IN OCTOBER 2017. THE FACILITY STATED THAT THE PICC WAS CRACKED WHERE THE CATHETER ENTERS THE HUB. CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7132369 ↗
• InjurySep 15, 2017Detachment Of Device Component; Material Fragmentation

  PER BARD CLINICAL SPECIALIST, THE FACILITY REPORTED THAT DURING PLACEMENT OF THE PICC LINE, THE ORANGE TABS BROKE OFF AND THE SHEATH DETACHED AND LODGED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THE IN ATTEMPT OF REMOVING THE SHEATH A CUT DOWN WAS MADE AND WAS UNSUCCESSFUL. REPORTEDLY, THE USE OF AN ANGIOPLASTY BALLOON WAS ABLE TO CAPTURE AND REMOVE THE SHEATH FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868457 ↗