PowerPICC Catheter 3276118Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741027994), received between Mar 1, 2017 and Apr 8, 2024 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionApr 8, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER TEAM OBSERVED WHEN OPENING MATERIAL IN THE ROOM THAT AFTER INSERTION OF THE ANGLING NEEDLE THE THREAD BROKE. THE PRODUCT WAS EXCHANGED FOR ANOTHER TO START THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060915 ↗
• MalfunctionDec 12, 2023Material Frayed; Material Frayed

  IT WAS REPORTED AFTER INSERTION OF THE NEEDLE, THE GUIDEWIRE WAS PASSED. WHEN ATTEMPTING TO REMOVE IT, THE GUIDE FAILED (BROKEN). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311153 ↗
• MalfunctionOct 30, 2019Failure to Infuse; Failure to Infuse

  IT WAS RELATED THAT THE CATHETER WAS OBSTRUCTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257344 ↗
• InjurySep 4, 2018Break; Material Disintegration

  IT WAS REPORTED THAT CATHETER POWER PICC SUCCESSFULLY PASSED THROUGH RIGHT BRAQUIAL VEIN. IT WAS STATED THAT DURING THE GUIDE WIRE REMOVING PROCEDURE, IT LEFT UNWRAPPING ONE OF EACH OTHER AND BROKE. WHEN THE CATHETER WAS TOTALLY REMOVED, IT WAS DISINTEGRATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7842508 ↗
• MalfunctionJun 21, 2017Difficult to Remove

  IT WAS REPORTED THAT THE PICC WAS PLACED SUCCESSFULLY, BUT WHILE REMOVING THE CATHETER THE GUIDEWIRE WOULD NOT PULL BACK. THE HEALTHCARE PROFESSIONAL USED PHYSIOLOGICAL SERUM AND TRIED TO PULL THE GUIDEWIRE, BUT NOTED THAT THE WIRE WAS THIN AND WAS GOING TO BREAK. IT WAS DECIDED TO REMOVE THE CATHETER AS THE WIRE COULD BREAK AND MIGRATE TO THE PATIENT BLOOD STREAM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6657742 ↗
• MalfunctionMar 1, 2017Fluid/Blood Leak

  FACILITY REPORTED INTERLUMINAL COMMUNICATION OR LEAKING BETWEEN THE LUMENS WHEN INJECTING SOLUTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370740 ↗