PowerPICC Provena S1274108D6Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741232213), received between Oct 29, 2025 and Mar 24, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 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.

• MalfunctionMar 24, 2026Difficult or Delayed Separation

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD A PICC WHERE THE INTRODUCER WOULD NOT BREAK OFF THE PICC. IT RESULTED IN AN OVER THE WIRE EXCHANGE DUE TO THE INTRODUCER PUNCTURING THE PICC AFTER WE GOT IT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674925 ↗
• MalfunctionMar 2, 2026Misassembled

  IT WAS REPORTED BY THE CUSTOMER THAT WITH THE DOUBLE LUMEN PICCS, SO FAR THREE OF THE KITS HAVE HAD THE SAME PROBLEM, THE CORNER THAT IS LEFT EXPOSED TO UNWRAP THE TRAY STARRILY IS THE WRONG CORNER. THE CORRECT CORNER WOULD BE THE TOPMOST CORNER (OPEN AWAY, THEN SIDE, SIDE, THEN BOTTOM TOWARD YOU). THE WAY IT IS NOW YOU HAVE TO OPEN THE BOTTOM MOST CORNER FIRST AND IT FLIPS EVERYTHING AROUND AND DOES NOT LEAVE A STERILE CORNER TO WORK WITH. ALSO, THE STEEL NEEDLE HAS TWICE FLIPPED OUT OF THE TRAY. PROBABLY DUE TO THE CHAOS OF TRYING TO UNWRAP THE IMPROPERLY WRAPPED TRAY. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES. ADDITIONAL INFORMATION RECEIVED 20 FEBRUARY 2026: NO NEGATIVE PATIENT IMPACT AT THIS TIME. THERE HAVE BEEN OCCASIONS WHERE THE NEEDLE HAS FALLEN OUT OF THE PACK BUT DID NOT IMPACT THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491880 ↗
• MalfunctionOct 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE NURSE ASSESSED PICC LINE AND FOUND IT TO BE OCCLUDED. WHEN SHE PULLED THE CATHETER, SHE NOTICED IT WAS KINKED IN TWO AREAS. THIS COULD HAVE BEEN FROM WHEN IT PASSED THE SHOULDER BUT WAS CONCERNED THAT THE PICC MATERIAL WAS WHITE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413338 ↗