PowerPICC Provena CK000898Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741184932), received between Mar 18, 2022 and May 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Product Quality Problem

  IT WAS REPORTED DURING INVESTIGATION ON 5/13/26: THE CATHETER RETURNED WAS OBSERVED TO ALSO HAVE A DAMAGED CLAMP/CLAMP NOT FUNCTIONING. USE RESIDUE WAS OBSERVED ON THE SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331886 ↗
• MalfunctionApr 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CRACK IN THE RED LUMEN 10 DAYS POST INSERTION THAT DOES NOT APPEAR TO BE FROM ANY BEDSIDE EVENT. PATIENT WAS END OF LIFE, PICC WAS REMOVED, NOT REPLACED, ADDITIONAL PIV ACCESS WAS ESTABLISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823516 ↗
• MalfunctionDec 3, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT SL PICC KITS SEEM TO BE VERY TIGHT IN PACKAGING AND DIFFICULT TO REMOVE/PLACE ON OUR STERILE FIELD FOR PROCEDURE. WE CAN EVEN CONTAMINATED A FEW TIMES TRYING TO REMOVE FROM PACKAGE, HAVING TO UTILIZE MORE SUPPLIES. THE OPENING OF THE PLASTIC PACKAGING IS NOT BIG ENOUGH TO SQUEEZE THE SUPPLIES OUT THROUGH. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704156 ↗
• MalfunctionMar 18, 2022Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "PICC LINE PLACED ON PATIENT'S LEFT ARM WHEN COMPLETED, THE INNER WIRE REMOVED AND THIS RN ASSESSED FOR PATENCY BEFORE DRESSING WAS COMPLETELY SECURED. IT WAS ASSESSED THAT THE RED LUMEN WAS OCCLUDED AND PURPLE LUMEN WAS FLUSHING WELL WITH POSITIVE BLOOD RETURN. THIS RN USED 1ST WIRE TO ASSESS RED LUMEN BY INSERTING IT INTO RED LUMEN OCCLUSION WAS NOTED AND FELT LIKE SOMETHING STUCK INTO CATHETER. PICC LINE REMOVED AND NEW ONE PLACED USING STERILE CATH EXCHANGE TECHNIQUE. UPON ASSESSING PREVIOUS PICC THE INNER WIRE WAS NOTED TO BE MISSING END COPPER TIP PART. PICC LINE FEELS LIKE WIRE JAMMED INTO CATHETER. MD NOTIFIED OF FINDINGS FOR POSSIBLE WIRE FRAGMENTATION. CHEST X-RAY ORDERED. CHEST X-RAY DID NOT SHOW ANYTHING CONCERNING PICC LINE AND WIRE PLACED INTO BIOHAZARD BAG AND PLACED INTO IV TEAM MANAGER'S BOX."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13806591 ↗