PowerPICC Provena SOLO S1295108FD1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741154805), received between May 7, 2022 and Oct 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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.

• MalfunctionOct 18, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER THAT PICC LINE NOT FLUSHING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959537 ↗
• MalfunctionAug 18, 2023

  NEEDLE WOULD NOT ALLOW GUIDEWIRE TO ADVANCE THROUGH DURING A PICC LINE INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 17585206 ↗
• MalfunctionMay 7, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "PRIOR TO CUTTING THEIR 3CG PICC, THEY PULLED BACK THE WIRE BUT STILL FOUND LEFTOVER WIRE IN THE END OF THE CATHETER THAT WAS TRIMMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317260 ↗
• MalfunctionMay 7, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "PRIOR TO CUTTING THEIR 3CG PICC, THEY PULLED BACK THE WIRE BUT STILL FOUND LEFTOVER WIRE IN THE END OF THE CATHETER THAT WAS TRIMMED." ADDITIONAL INFORMATION RECEIVED 04/19/2022 ¿WHILE INSERTING A DLPICC PT WAS PREPPED AND MEASURED FOR LINE LENGTH. THE CATHETER WAS FLUSHED AND THE GUIDE WIRE WAS RETRACTED TO THE APPROPRIATE LENGTH AND THE CATHETER WAS TRIMMED. THE GUIDE WIRE WAS THEN REINSERTED TO THE TIP OF THE LINE TO OBTAIN AN ACCURATE SHERLOCK READING. THE LINE WAS INSERTED WITHOUT INCIDENT PROPER PLACEMENT CONFIRMED BY SHERLOCK TECHNOLOGY. WHILE CLEANING UP I NOTICED A 3.5CM PIECE OF MAGNETIC WIRE. ON THE FIELD . I THEN MEASURED THE GUIDEWIRE IN THE CATHETER WHICH WAS 3.5 CM SHORT THE ENTIRE WIRE IS 78CM THE MAGNETIC TIP IS 7.5CM. I PLACED ANOTHER DLPICC IN THE PTS ROOMMATE AND MEASURED THE WIRE POST PROCEDURE IT WAS 78CM LONG WHICH INCLUDED AND INTACT 7.5CM MAGNETIC TIP.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316626 ↗