PowerPICC Provena S1385108D2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741154867), received between Jan 26, 2022 and Jun 23, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionJun 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THE GREY PART OF THE MICROINTRODUCER WAS BENT AND NURSE COULD NOT FULLY GET INTO PATIENT. ADDITIONAL INFORMATION RECEIVED 03 JUNE 2025: IT WAS REPORTED "DURING A ROUTINE PICC LINE PLACEMENT IN THE UPPER LEFT ARM, THE PROCEDURE PROCEEDED NORMALLY UNTIL THE INTRODUCTION OF THE PEEL-AWAY INTRODUCER. AFTER MAKING A STANDARD SMALL SKIN INCISION AT THE GUIDEWIRE ENTRY SITE, I ATTEMPTED TO ADVANCE THE INTRODUCER OVER THE GUIDEWIRE AND THROUGH THE SUPERFICIAL TISSUE LAYERS. UNEXPECTED RESISTANCE WAS ENCOUNTERED. UPON WITHDRAWAL OF THE INTRODUCER, I OBSERVED THAT THE GRAY OUTER COMPONENT OF THE DEVICE WAS VISIBLY FOLDED AND TORN, COMPROMISING ITS STRUCTURAL INTEGRITY. THIS OCCURRED DESPITE THE USE OF STANDARD TECHNIQUE AND APPROPRIATE INSERTION FORCE. FOLLOWING REMOVAL, A SPHERICAL HEMATOMA APPROXIMATELY THE SIZE OF A SILVER DOLLAR DEVELOPED UNDER THE SKIN, ALONG WITH ACTIVE BLEEDING AT THE ENTRY SITE. A SECOND TRIPLE LUMEN PICC KIT WAS OPENED, AND THE INTRODUCER FROM THAT KIT ADVANCED WITHOUT COMPLICATION THROUGH THE SKIN AND INTO THE SELECTED VESSEL. DESPITE SUCCESSFUL ADVANCEMENT OF THE SECOND INTRODUCER, THE OVERALL PICC ATTEMPT WAS ULTIMATELY DISCONTINUE

  Patient problems: Hematoma

  MAUDE report 22309640 ↗
• MalfunctionFeb 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TRIPLE LUMEN CATHETER WAS CRACKED AT THE BASE OF THE LUMEN. WHILE CONDUCTING THE FLUSH ON THE PORT NOTICED THAT IT WAS LEAKING OUT OF THE SIDE PORT. CHANGED THE WIRE OUT. DISPOSED OF IT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669058 ↗
• MalfunctionDec 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "STYLET STOPPER SEEMED TO BE BROKEN AND LEAK WHEN FLUSHING AFTER PLACEMENT" NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950188 ↗
• MalfunctionJan 26, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "AFTER REMOVING THE WIRE INSIDE THE PICC DURING INSERTION IT WAS RECOGNIZED THAT THE TIP OF THE WIRE WAS BENT AND AFTER CLOSER OBSERVATION THE TIP WAS NOTED TO BE BROKEN OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359543 ↗