PowerPICC Catheter 3175135Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741027673), received between Mar 28, 2016 and Oct 15, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED, BROKEN LINE. ADDITIONAL INFORMATION PROVIDED 09-OCT-2025: CATHETER BREAK WAS EXTERNAL TO THE PATIENT. IT IS UNKNOWN IF THE BREAK WAS COMPLETE OR PARTIAL. THE PATIENT DID NOT HAVE ANY SYMPTOMS ASSOCIATED WITH THE BREAK. NOTHING WAS INFUSING AT THAT POINT OF TIME. INTERVENTION INCLUDED REMOVAL AND REPLACEMENT OF NEW PICC. THERE WAS NO DELAY IN TREATMENT. CATHETER WAS SECURED WITH PICC STATLOCK AND DRESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294816 ↗
• MalfunctionOct 15, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THE STATLOCK NOT STICKY EVEN THOUGH IT IS PUT ON FOR 1 DAY ONLY. CUSTOMER CONFIRMED SKIN PREP PAD WAS USED PRIOR TO APPLYING THE STATLOCK. THE EVENT DID NOT CAUSE THE CATHETER TO DISLODGE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285721 ↗
• MalfunctionDec 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "5FR GUIDEWIRE FOLDS OVER ON ITSELF IN IR PLACEMENT." ADDITIONAL INFORMATION PROVIDED: IT WAS REPORTED BY THE CUSTOMER, THAT THE CATHETER WAS SUTURED IN PLACE AFTER INSERTION. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034985 ↗
• InjuryOct 25, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT GUIDEWIRE TIP BROKE OFF. "WHAT ARE THE DETAILS OF THE INCIDENT?": PICC LINE WIRE INSERTED THROUGH NEEDLE ONCE NEEDLE WAS IN THE VEIN. WIRE HAD DIFFICULTY ADVANCING. AS GUIDEWIRE WAS BEING RETRACTED THROUGH THE SKIN, TIP BROKE OFF AND WAS LEFT INSIDE THE PATIENTS ARM. THE BROKEN PIECE WAS REMOVED OPERATIVELY. FOUND NOT TO BE INTRA-VASCULAR, NO REPORTED COMPLICATIONS POST-OP. DATE OF INCIDENT: (B)(6) 2022. "WHAT WAS THE TYPE OF INCIDENT/PROBLEM?" FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE). "WHAT WAS THE LEVEL OF HARM?" : HARM OR CLINICALLY SERIOUS ADVERSE EVENT. "DID THIS PROBLEM/INCIDENT RESULT IN UNEXPECTED OR PROLONGED CARE?" : YES "WHAT IS THE FREQUENCY OF THIS PROBLEM?" : FIRST TIME. "WAS THIS AN INVASIVE PROCEDURE?" : YES. "WHAT PROCEDURE?" : PICC LINE INSERTION WITH REMOVAL OF RETAINED PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15671204 ↗
• MalfunctionJun 2, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT GUIDEWIRE WAS FOUND KINK DURING INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14581037 ↗
• MalfunctionSep 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LUMEN WAS LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10512086 ↗
• InjuryAug 3, 2018Entrapment of Device; Retraction Problem; Unraveled Material

  IT WAS REPORTED THAT AFTER THE PUNCTURE IN THE LEFT BASILICA VEIN WITH THE PUNCTURE NEEDLE, THE GUIDE WAS INSERTED. IT WAS STATED DURING THE GUIDE WITHDRAWAL IT DIDN'T COME OUT. AFTER READJUSTMENTS, THE DOCTOR WAS STILL TRYING TO WITHDRAWAL IT AND DECIDED TO REMOVE IT WITH THE PUNCTURE NEEDLE. THE NEEDLE WAS REMOVED SUCCESSFULLY, HOWEVER IT WAS REPORTED THE GUIDE WAS STILL STUCK INSIDE THE VEIN AND DURING ITS WITHDRAWAL THE TIP FELL APART, LIKE IT WAS UNRAVELING, LEAVING PART OF THE MATERIAL (THIN LINES OF THE NEEDLE TIP) INSIDE THE PATIENT'S VEIN, WHICH WAS CONFIRMED BY RADIOSCOPY (RADIOPAQUE MATERIAL IN THE PATIENT'S ARM AFTER THE WITHDRAWAL OF THE NEEDLE AND GUIDE). IT WAS NECESSARY THE SURGICAL WITHDRAWAL OF THE MATERIAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7748557 ↗
• MalfunctionSep 6, 2017Cut In Material

  WHILE PREPARING FOR THE PICC PROCEDURE, IT WAS FOUND THAT THE GUIDEWIRE WAS CUT AND COULD NOT BE USED FOR THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 6847268 ↗
• MalfunctionMar 28, 2016Difficult to Insert; Kinked; Sticking; Unraveled Material

  ON (B)(6) 2016- IT WAS REPORTED THAT THE PATIENT WAS PREPPED FOR PICC INSERTION AND THE DOCTOR INSERTED THE GUIDEWIRE AND ENCOUNTERED DIFFICULTY WHILE THREADING THE WIRE THROUGH THE VESSEL. IT REPORTEDLY KINKED AND WAS STUCK AND WHEN HE TRIED TO MOVE IT, IT UNRAVELED. THE DOCTOR WAS ABLE TO REMOVE ALL THE WIRE FROM THE VESSEL. A NEW PICC SET WAS OPENED AND THE GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5530628 ↗