PowerPICC Provena S3395108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741112836), received between May 20, 2022 and Aug 8, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE STIFFENING WIRE IN THE BARD PICC BENDS AND CANNOT BE ADVANCED ONCE THE STIFFENING WIRE IS ALTERED. HAD TO USE 3 PICC LINE KITS ON THIS PATIENT. STIFFENING WIRE INSIDE PICC LINE BENT AT A 90 DEGREE APPROXIMATELY 15 CM FROM HUB. UNABLE TO FULLY THREAD PICC LINE AFTER WIRE BENT. HAD TO TRIM THE PICC LINE TO WHERE THE STIFFENING WIRE BENT TO USE PICC LINE. IT WAS REPORTED THAT THREE DIFFERENT PICC KITS WITH THREE DIFFERENT MATERIAL NUMBERS WERE USED. THIS REPORT ADDRESSES THE SECOND KIT AND MATERIAL NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481183 ↗
• MalfunctionMay 20, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED PICC LINE WAS PLACED BUT NEEDED REPOSITIONING. UPON REPOSITION ATTEMPT, DID NOT EASILY WITHDRAW (MET SLIGHT RESISTANCE). UPON WITHDRAWAL, THE PICC LINE INTERNAL STIFFENING WIRE HAD 2 BENT AREAS. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STAT LOCK. PLACEMENT DATE: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461932 ↗