PowerPICC Provena S1395108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741112744), received between Oct 11, 2019 and Dec 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2020Migration or Expulsion of Device; Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE CUSTOMER HAS A 5FR. PROVENA TRIPLE PICC THAT MIGRATED TO THE NECK. ADDITIONAL INFORMATION RECEIVED 12/09/2020: IT WAS STATED THE CXR SHOWED LOOP IN CATHETER IN THE UPPER CHEST AREA CATHFLOW AND POWER FLUSHING NOT EFFECTIVE PICC PULLED BACK AND MADE INTO A MIDLINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11061891 ↗
• MalfunctionDec 21, 2020Migration or Expulsion of Device

  IT WAS REPORTED A 5FR. PROVENA TRIPLE PICC MIGRATED TO THE NECK. ADDITIONAL INFO. RECEIVED 12/09/2020. "THE PICC LINE THAT ARRIVED WITH THE PICC IN THE RIGHT IJ. PICC WAS FLUSHED OUT OF THE IJ BY THE STAFF AND THE LINE WAS MID-SVC, NOT CAJ."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11049377 ↗
• MalfunctionOct 11, 2019Break; Break

  IT WAS REPORTED THAT THE PICC WAS PLACED IN THE ARM OF PATIENT AND THE EXTERNAL LUMEN WAS BROKEN IN TWO PIECES WHEN DOING THE DRESSING CHANGE. NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9179873 ↗