PowerPICC Provena S3173355Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741129971), received between Aug 30, 2017 and Dec 19, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Crack” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Material Frayed; Material Frayed

  IT WAS REPORTED WENT TO PLACE PICC LINE IN CPC ON PATIENT. OBTAINED ACCESS TO THE LEFT BRACHIAL VEIN X 1 ATTEMPT WITHOUT ANY ACCESS ISSUES. THREADED GUIDEWIRE IN WITH EASE INITIALLY BUT THEN MET RESISTANCE. PULLED GUIDEWIRE OUT AND IT REDREW EASILY. THEN APPLIED A HOT PACK TO THE CHEST/SHOULDER AND ATTEMPTED TO REPOSITION ARM SO THAT GUIDEWIRE WOULD POTENTIALLY THREAD IN SMOOTHER. I HAD THE SAME EXPERIENCE OF IT GOING IN SMOOTHLY AT FIRST AND THEN MEETING RESISTANCE. WENT TO PULL GUIDEWIRE OUT AND IT CAME OUT SMOOTHLY AT FIRST AND THEN I MET RESISTANCE. CALLED IR AND DR CAME TO THE BEDSIDE. DR REMOVED THE GUIDEWIRE AND WITH REMOVAL IT BECAME FRAYED. DR RECOMMENDED THAT WE OBTAIN A CHEST X-RAY AND THE X-RAY SHOWED A SMALL PORTION OF THE TIP OF THE GUIDEWIRE IN THE LEFT ARM. THE ATTENDING DOCTOR WILL NOT CONDUCT A PROCEDURE TO REMOVE THE FRAGMENT. THE PICC LINE WAS REPLACED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23851361 ↗
• MalfunctionAug 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED "PICC PLACED IN OR BY PICC RN USING A C-ARM AND SHERLOCK. TIP NEAR CAJ. CXR DONE IMMEDIATELY AFTERWARDS PER POLICY AND PICC HAD MIGRATED CONTRALATERAL." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277614 ↗
• MalfunctionMay 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PER MOTHER ¿LEAKING FROM A HOLE IN THE RE-ENFORCED AREA OF END OF TUBING WHERE CAP ATTACHES¿ PLACED (B)(6) 2021. SECURED WITH STATLOCK. BROKE (B)(6) 2021. REMOVED (B)(6) 2021. PATIENT HAD TO COME INTO THE HOSPITAL AND GET ANOTHER PICC LINE PLACED IN IR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790978 ↗
• MalfunctionOct 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HUB BROKE OFF OF THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257057 ↗
• MalfunctionApr 6, 2018Fracture

  IT WAS REPORTED THAT THE PATIENT'S PICC WAS "COMPLICATED BY A FRACTURE OF AN EXTERNAL COMPONENT, REQUIRING REPLACEMENT.". NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7403714 ↗
• MalfunctionMar 21, 2018Crack

  IT WAS REPORTED THAT THE PICC CRACKED AT THE DISTAL END/HUB. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7359189 ↗
• MalfunctionMar 19, 2018Crack

  PER COMPLAINANT: MULTIPLE INSTANCES OF PICC LINES FROM MULTIPLE LOTS CRACKING AT THE DISTAL END/HUB. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7351328 ↗
• MalfunctionOct 24, 2017Break

  IT WAS REPORTED BY THE FACILITY THAT THE PROVENA LINE IS BREAKING DIRECTLY BELOW THE PURPLE HUB CONNECTOR. THE FACILITY STATED THAT THE PATIENT HAD TO RETURN TO RADIOLOGY TO HAVE ANOTHER LINE PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6974837 ↗
• MalfunctionSep 21, 2017Detachment Of Device Component

  IT WAS REPORTED BY THE SALES REP THAT THE 3 FR POWER PICC CATHETER SEPARATED AT THE HUB. NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6883362 ↗
• MalfunctionSep 7, 2017Material Frayed

  FACILITY REPORTED TO SALES REP THAT THEY HAD A CATHETER FRAY NEAR THE HUB. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6850038 ↗
• MalfunctionAug 30, 2017Hole In Material

  FACILITY REPORTED TO THE SALES REP A PINHOLE PUNCTURE IN THE DEVICE. NO OTHER INFORMATION WAS REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6832768 ↗