PowerPICC Provena S3274108Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741130168), received between Oct 20, 2017 and Mar 18, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Failure to Infuse

  IT WAS REPORTED THAT DURING A DIFFICULT CATHETER INSERTION, THE RN NOTED THAT THE RED LUMEN WAS DIFFICULT TO FLUSH AND THEY COULD NOT OBTAIN A BLOOD RETURN. STYLET THAT IS IN THE RED LUMEN FROM THE MANUFACTURER WAS REMOVED DURING PROCEDURE. PURPLE LUMEN HOUSED THE ADDED ARROW BRAND VASCULAR POSITIONING STYLET AND THIS LUMEN REMAINED PATENT THROUGHOUT THE PROCEDURE, EASY TO FLUSH WITH BLOOD RETURN. SUSPECTING THE PICC MAY BE KINKED OR "KNOTTED", SHE RETRACTED THE PICC A FEW CM AT A TIME TO ASSESS PATENCY. NO AMOUNT OF RETRACTING THE PICC DURING THE PROCEDURE RE-ESTABLISHED PATENCY. THIS PICC WAS REMOVED AND ANOTHER PICC KIT WAS OPENED TO COMPLETE THE PROCEDURE. ONCE THE FAULTY PICC WAS REMOVED FROM THE PT, WRITER ATTEMPTED TO FLUSH THE RED LUMEN, AGITATE WITH FLUID, ETC WITH ONLY DRIPS OF FLUID PASSING THROUGH THE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634081 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED CATHETER WAS FOUND WITH A HOLE JUST DISTAL TO THE HUB, DISCOVERED DUE TO LEAKAGE UNDER THE DRESSING. IV MEDICATION TREATMENT WAS INTERRUPTED, AND PATIENT HAD TO UNDERGO AN EXCHANGE OF THE LINE. LINE WAS SECURED WITH SECURACATH. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337395 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED CATHETER WAS FOUND WITH A HOLE JUST DISTAL TO THE HUB, DISCOVERED DUE TO LEAKAGE UNDER THE DRESSING. IV MEDICATION TREATMENT WAS INTERRUPTED, AND PATIENT HAD TO UNDERGO AN EXCHANGE OF THE LINE. LINE WAS SECURED WITH A SUTURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337392 ↗
• MalfunctionJul 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON 3 FR PICC KITS THAT HAVE THE NEW DRESSING DOES NOT ADHERE TO THE PATIENT'S SKIN. IT WAS STATED THIS HAS OCCURRED WITH EVERY PATIENT HOWEVER AN EXACT QUANTITY WAS NOT PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103686 ↗
• InjuryOct 20, 2017Break; Device Or Device Fragments Location Unknown

  IT WAS REPORTED BY THE FACILITY THAT THE DEVICE WAS PLACED IN THE LEFT CEPHALIC VEIN AND THEY WERE UNABLE TO DETERMINE THE EXACT LOCATION OF THE SUSPECTED GUIDEWIRE BREAK. THEY REPORTED THAT THE GUIDEWIRE EMBOLI ZED IN THE DISTAL PULMONARY ARTERY BRANCH AND THAT THE GUIDEWIRE HAS NOT BEEN REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6965378 ↗