PowerPICC Provena S1275108FD4Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741155062), received between Jan 11, 2024 and Feb 11, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A 5F DUAL LUMEN PICC WAS LEAKING UNDER THE SECURACATH DEVICE ON THE OUTSIDE OF THE PATIENT. IT WAS REPORTED THAT THE PICC HAD TO BE PULLED AND REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317474 ↗
• MalfunctionSep 12, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE GREEN SAFETY IS SLIDING OFF OF THE NEEDLE AND EXPOSING THE NEEDLE TIP. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208432 ↗
• MalfunctionAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NURSE INSERTED OUR PROVENA PICC USING OUR MASK IN THE KIT AND GOT NASAL AND THROAT IRRITATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Sore Throat

  MAUDE report 20057944 ↗
• MalfunctionAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT NURSE INSERTED PICC AND GOT NASAL AND THROAT IRRITATION FROM OUR MASK IN THE PICC KIT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: Sore Throat

  MAUDE report 20044955 ↗
• MalfunctionJan 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PATIENT SEEN IN THE ED WENT TO CT SCAN AND IT WAS NOTED THAT PICC LEAKING AFTER RETURNING FROM CT SCAN. PICC PLACED AT ANOTHER FACILITY AND BEING CARED FOR AT HOME. PICC REMOVED AND IT WAS NOTED TO BE RUPTURED AT THE 3 CM MARK, WHICH HAPPENED TO BE THE PATIENT'S EVL WHILE IN PLACE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491364 ↗