Poly RadPICC Catheter 3265135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741035104), received between Aug 24, 2017 and May 23, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2018Break

  IT WAS REPORTED THAT THE CATHETER BROKE INTO TWO PIECES WHEN THE NURSE WANTED TO DO A DRESSING ON A THE PATIENT AFTER COMPLETING CLOXA. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7536743 ↗
• MalfunctionMar 2, 2018Crack

  IT WAS REPORTED THAT THE PICC WAS INSERTED ON (B)(6) 2017. THEY FOUND A CRACK AT THE HUB ON (B)(6) 2018 AND THEY HAD TO REINSERT A NEW PICC. THERE WERE NO REPORTS OF PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311561 ↗
• MalfunctionDec 29, 2017Fluid/Blood Leak

  IT WAS REPORTED BY THE NURSE THAT SHE FOUND THE PATIENT'S BED WAS WET; FOUND THE IMPLICATED PICC LEAKING. THE NURSE THEN ALLEGEDLY CLAMPED THE RED-LUMEN AND THE LEAKING STOPPED. CATHETER WAS REMOVED AND A NEW CATHETER WAS RE-INSERTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7154581 ↗
• MalfunctionAug 24, 2017Kinked; Difficult to Remove

  IT WAS REPORTED THAT THE DOCTOR COULD NOT REMOVE THE GUIDEWIRE FROM THE CATHETER BECAUSE IT WAS KINKED INSIDE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6817251 ↗