PowerPICC Provena CK000993Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741213311), received between Jul 29, 2022 and Mar 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC LINE WAS ORIGINALLY PLACED ON (B)(6) 2025 IN RIGHT BASILIC VEIN. PICC LINE HAS BEEN WORKING FINE WITHOUT ANY CONCERNS OR ISSUES. A PRN DRESSING CHANGE WAS PERFORMED YESTERDAY (B)(6) 2025 AND AT THAT TIME DID NOT NOTICED ANY LEAKING. ON 2/20/25, THEIR TEAM RECEIVED A CONSULT FOR A LEAKING PICC LINE. THEY REMOVED THE DRESSING AND FLUSHED CATHETER AND NOTICED THAT NORMA SALINE WAS SPURTING OUT OF THE CATHETER AT THE 0 CM MARKER. PICC LINE WAS THEN REMOVED AND ON INSPECTION IF WAS NOTED THAT THERE IS A VISIBLE SLIT IN THE CATHETER NOTED AT THE AREA OF WHERE THE SALINE WAS SPURTING OUT FROM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574482 ↗
• MalfunctionOct 10, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT CHANGE TO THE END CAPS THAT COME IN THEIR TRIPLE LUMEN CUSTOM PICC KITS. SO FAR, THIS ISSUE HAS BEEN ISOLATED TO A SINGLE LOT. THE CAP HAS A POINTED END AND NOT ONLY DOES IT HAVE A POINTED END IT HAS SMALL HOLE ALL THE WAY THROUGH SO BLOOD ACTUALLY STILL COMES OUT WHICH CAN ALSO ALLOW AIR IN. THESE CAPS ARE PUT ON THE INTRODUCER SHEATH ONCE YOUR WIRE IS REMOVED TO PREVENT BLOOD FROM COMING OUT OF THE SECURED VEIN/SITE, SO YOU HAVE TIME TO GET YOUR PICC CONNECTED TO THE SHERLOCK ETC. THE POINTED CAPS DO NOTHING TO PREVENT BLOOD OR AIR FROM COMING IN OR OUT AND HAS AFFECTED THIS TRIPLE LUMEN PICC LOT NUMBER. NO OTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418116 ↗
• MalfunctionJul 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "REPEATED MECHANICAL OCCLUSIONS - PICC REPLACED WITH SL PICC, KINK AT 13 CM." ADDITIONAL INFORMATION RECEIVED 07/20/2022: IT WAS REPORTED "THIS PICC WAS PLACED ON (B)(6) - KINK FOUND ON DAY ((B)(6)). THE LINE WAS WITHDRAWN 2 CM WITH RESOLUTION OF KINK AND PATENCY RESTORED. (B)(6) PICC OCCLUDED AGAIN AND COULD NOT BE RESTORED, LINE WAS REMOVED WITH KINK SHOWING AT 13 CM. NEW PICC PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135886 ↗