PowerPICC® FT Catheter 3275355FRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741027970), received between Jan 5, 2017 and Oct 15, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED 11/04/2025: CATHETER WAS STABILIZED WITH TEGADERM IV. THE CATHETER WAS REMOVED DUE TO END OF TREATMENT. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS ASSOCIATED WITH THE PICC NOTCH. IT IS UNKNOWN IF THE ENTIRE CATHETER WAS REMOVED FROM THE PATIENT SINCE THE NOTCHED END FOLLOWED AT THE REMOVAL BUT THE LENGTH AT THE INSTALLATION WAS MISSING ON THE CARD AND THE RADIOLOGIST¿S NOTE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292953 ↗
• MalfunctionApr 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "PICC PLACED ON (B)(6) 2023 FOR DAILY INFUSION. NOTED LEAK AT PURPLE PORT ON (B)(6) 2023 PICC LINE REMOVED. MIDLINE PLACED TO COMPLETE TREATMENT. NO PATIENT HARM.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667780 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA HEALTH (B)(6) MEDICAL DEVICES ONLINE DATABASE: "E1906 - UNSPECIFIED INFECTIONF12 - SERIOUS INJURY ILLNESS IMPAIRMENTA26 - INSUFFICIENT INFORMATION." NO OTHER INFORMATION REGARDING THE EVENT WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12310470 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTH (B)(6) WEBSITE THAT A FACILITY REPORTED A UNSPECIFIED INFECTION. AN UNEXPECTED MEDICAL INTERVENTION AND SERIOUS INJURY ILLNESS IMPAIRMENT WAS REPORTED. NO FURTHER INFORMATION. CAUSE NOT ESTABLISHED.

  Patient problems: Unspecified Infection

  MAUDE report 10679558 ↗
• InjurySep 14, 2017Material Fragmentation

  IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP, THAT THEY HAD A PICC, WHICH WAS PLACED EASILY. HOWEVER, UPON THE GUIDEWIRE EXTRACTION, THE TIP OF THE GUIDEWIRE BROKE OFF AND REMAINED IN THE PATIENT. THE TIP OF THE GUIDEWIRE WAS REMOVED BY THE INTERVENTIONAL PHYSICIAN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6865262 ↗
• MalfunctionJan 5, 2017Break; Separation Failure

  PER SALES REPRESENTATIVE, THE FACILITY REPORTED THAT DURING THE PROCEDURE ON TWO OCCASIONS THE PEEL AWAY SHEATH WOULD NOT COME APART. IT WAS STATED THAT THE TIP BROKE ON ONE DUE TO THE "AGGRESSIVE FORCE" NEEDED TO PEEL IT. NO PATIENT HARM WAS REPORTED. THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6227310 ↗
• MalfunctionJan 5, 2017Break; Separation Failure

  PER SALES REPRESENTATIVE, THE FACILITY REPORTED THAT DURING THE PROCEDURE ON TWO OCCASIONS THE PEEL AWAY SHEATH WOULD NOT COME APART. IT WAS STATED THAT THE TIP BROKE ON ONE DUE TO THE "AGGRESSIVE FORCE" NEEDED TO PEEL IT. NO PATIENT HARM WAS REPORTED. THIS REPORT ADDRESSES THE FIRST EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6227308 ↗