PowerPICC Provena SOLO CK000931ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741220043), received between Jan 3, 2025 and Apr 6, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Crack

  IT WAS REPORTED, PLACED A PICC SUCCESSFULLY THEN THEY HAD NO BLOOD RETURN AND NOTICED AIR IN SYRINGE. THEY REALIZED THERE WAS A CRACK IN THE RED HUB. IT WAS LEAKING SALINE WHEN FLUSHED. PLACED A NEW PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791911 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD A LEAKING PICC. IT WAS LEAKING DOWN FROM THE HUB WHEN THEY FLUSHED IT WITH SALINE. PICC REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22444416 ↗
• MalfunctionMay 9, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED OVER LAST SEVERAL DAYS THE TEAM HAS NOTICED THAT THE DILATORS IN THE CUSTOM PICC KIT HAVE NOT BEEN PASSING EVEN WITH DOUBLE DILATE. WHEN A NEW SINGLE PACK SEPARATE DILATOR IS ADDED, IT SLIDES IN LIKE BUTTER. I INSPECTED ONE YESTERDAY AND IT DID NOT APPEAR TO BE CRACKED, ROLLED OR TORN. MOST OF US RARELY DOUBLE DILATE WHICH PROMPTED US TO TRY SCRAPPING THE DILATOR IN THE KIT AND ADDING A NEW ONE. THEY SAID IT AT LEAST HAPPENED 4 TIMES, AND PROBABLY 4 MORE. IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES ALL EIGHT DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997532 ↗
• MalfunctionApr 24, 2025Defective Component; Patient-Device Incompatibility; Defective Component; Patient-Device Incompatibility

  IT WAS REPORTED THE DIAPHRAGM ON THE INTER LUMINAL WIRE HEAD WAS PREVENTING THE LUMEN FROM FLUSHING OR DRAWING. I ATTEMPTED TO FLUSH IT AND THE DIAPHRAGM EXPLODED SPRAYING ALL OF US WITH SALINE. ONCE THE WIRE WAS REMOVED THE CATHETER WAS FULLY FUNCTIONAL AND IN THE RIGHT PLACE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903858 ↗
• InjuryMar 28, 2025Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED, PICC PATIENT DEVELOPED A DVT IN 24 HOURS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21722132 ↗
• MalfunctionJan 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "WE CAME ACROSS A FAULTY PICC LINE. WE DID NOT RECOGNIZE IT UNTIL THE PICC HAD BEEN PLACED AND WE WERE DOING THE FINE TUNING OF WHERE TO LEAVE THE PICC LINE. THE RED LUMEN AND ONLY THE RED LUMEN STARTED LEAKING WHEN FLUSHING. IT WAS LEAKING WHERE THE LUMEN CONNECTS TO THE BARD WINGS THAT OUR STATLOCK CONNECTS TO. WE ENDED UP REMOVING THE PICC AND REPLACING IT WITH ANOTHER DOUBLE LUMEN AND DIDN'T HAVE ANY ISSUES." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069130 ↗