PowerPICC Provena S3274335Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741130045), received between Mar 16, 2018 and Oct 25, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, CATHETER WAS PLACED AT ONE FACILITY AND CRACKED WHILE PATIENT WAS AT A DIFFERENT FACILITY. THERE WAS NO NEGATIVE IMPACT OR HARM AND THE CATHETER WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537415 ↗
• InjuryMay 1, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER THE POWER PICC THAT WAS PLACED AND NOW, THE POWER PICC IS HAVING TROUBLE INFUSING AND DRAWING BACK. PATIENT HAS CRITICAL MEDICATIONS RUNNING IN THEIR POWER PICC CONTINUOUSLY AND WHEN THEY DON'T INFUSE PROPERLY, THEY MISS THEIR MEDICATIONS AND DECOMPENSATE. PATIENT IS UNDER A YEAR OF AGE AND THE LINE IS PLACED IN THEIR FEMORAL VEIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842413 ↗
• MalfunctionApr 26, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED "CALLER STATES CLOTTING IN THE POWERPICC PROVENA CATHETER PLACED IN PEDIATRIC PATIENT. PRODUCT CODE S3274335 LOT# REGR1311 WAS PLACED AND CLOTTED AND EXCHANGED OVER A WIRE. RESPONSE: EMAILED POWERPICC PROVENA INSTRUCTIONS AND DISCUSSED FLUSHING RECOMMENDATIONS.". ADDITIONAL INFO RECEIVED ON 9 APRIL 2023: PATIENT HAS CRITICAL MEDICATIONS RUNNING IN THEIR POWER PICC CONTINUOUSLY AND WHEN THEY DON'T INFUSE PROPERLY THEY MISS THEIR MEDICATIONS AND DECOMPENSATE. PATIENT IS FEMALE UNDER A YEAR OF AGE AND THE LINE IS PLACED IN THEIR FEMORAL VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815688 ↗
• MalfunctionOct 30, 2019Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED, "RESULTED IN NEED FOR EMERGENT OVERWIRE EXCHANGED OF PICC WITH PATIENT DRIPS ON HOLD X 30 MINUTES." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257052 ↗
• MalfunctionApr 19, 2018Detachment Of Device Component; Nonstandard Device; Torn Material

  PER MEDWATCH; REPORTEDLY, CALLED TO ASSESS PICC LINE BECAUSE OF A REPORT THAT IT HAS A TEAR IN THE LUMEN. WHEN I LOOKED AT PICC LINE THE PURPLE HUB AND CAP WAS ONLY BARELY ATTACHED TO THE PICC LUMEN. WHEN I TURNED THE PURPLE CAP TO ASSESS IT, THE PURPLE LINE CAME OFF IN MY HAND. THE PICC LINE WAS THEN REMOVED AND NURSE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7445749 ↗
• MalfunctionApr 5, 2018Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD A DOUBLE LUMEN POWER PICC PLACED AT IR. THE PATIENT WAS REFERRED BACK TO IR FOR PICC REPLACEMENT AS IT WAS REPORTED THAT ONE LUMEN WAS COMPLETELY BROKEN AND A SECOND LUMEN WAS LEAKING. THE PICC WAS REPLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7401389 ↗
• MalfunctionMar 16, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE HUB BROKE AWAY FROM THE LUMEN OF THE CATHETER. NURSE NOTED THAT IT LOOKED AS IF IT HAD BEEN CUT OFF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7345700 ↗