PowerPICC Provena CK000291CRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741161162), received between Aug 8, 2019 and Jan 5, 2026 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED, VERTICAL CRACK IN CATHETER NEAR THE 7CM MARK. ADDITIONAL INFORMATION RECEIVED 12/19/2025: THE PATIENT HAD TO RECEIVE A NEW PICC LINE DUE TO THE MALFUNCTION WITH THE LINE THAT WAS IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958395 ↗
• MalfunctionMay 1, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED HAIR WAS FOUND IN PICC KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942095 ↗
• MalfunctionAug 18, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THE WIRE TIP BROKE OFF AFTER UNSUCCESSFUL PICC PLACEMENT. MET RESISTANCE AT THE 15CM MARK AND PULLED THE WIRE TO CHECK ON INTEGRITY AND IT BROKE OFF ONCE OUTSIDE OF THE PATIENT AND AFTER INTEGRITY CHECK. ADD INFO RCVD 08/11/2021: PLACEMENT INFO: INCIDENT OCCURRED 7/28/2021. INSERTER ATTEMPTED DOUBLE LUMEN POWERPICC PROVENA INSERTION FOR PATIENT NEEDING CHEMOTHERAPY TREATMENTS. ENCOUNTERED RESISTANCE, UNABLE TO PASS INTO CHEST. WHEN PICC REMOVED AND GUIDEWIRE INSPECTED, COPPER TIP OF WIRE FELL OUT OF END OF PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340421 ↗
• MalfunctionJan 20, 2021Material Twisted/Bent

  IT WAS REPORTED UNABLE TO GET WIRE TO CROSS THE SHOULDER DURING INSERTION. THE WIRE WAS PULLED OUT OF THE PATIENT AND A BEND IN THE WIRE WAS NOTICED. ON (B)(6) 2020: DURING DEVICE EVALUATION THE WIRE WAS FOUND TO BE KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205379 ↗
• MalfunctionOct 13, 2020Fracture

  IT WAS REPORTED THE ECG WIRE FRACTURED ON THE 5FR. TRIPLE LUMEN PICC. IT WAS STATED IT WAS AN UNSUCCESSFUL PICC AND DID NOT REACH THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674146 ↗
• InjuryOct 13, 2020Fracture

  IT WAS REPORTED THE ECG WIRE FRACTURED ON THE 5FR. TRIPLE LUMEN PICC. IT WAS STATED IT WAS A SUCCESSFUL PICC PLACEMENT AND DID REACH THE PATIENT BUT WAS NOT RETRIEVED. DETERMINATION OF SOURCE OF THE WIRE WAS CONFIRMED DUE TO PRE AND POST PLACEMENT CXR.

  Patient problems: Foreign Body In Patient

  MAUDE report 10672927 ↗
• MalfunctionJan 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC RUPTURED NEAR THE EXTERNAL GREY LUMEN NEAR THE HUB DURING FLUSHING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9627039 ↗
• MalfunctionAug 8, 2019Leak/Splash

  IT WAS REPORTED THAT THE PICC WAS LEAKING. THE NURSE STATED IT WAS NOT LEAKING FROM THE INSERTION SITE. WHEN FACILITY CONTACT ASSESSED THE PICC, SHE FOUND IT WAS LEAKING FROM NEAR WHERE THE GRAY PORT ATTACHES TO THE SUTURE WING. IT WAS STATED THE PICC DID NOT LEAK ALL THE TIME, JUST WHEN THE LINE WAS MOVED IN A CERTAIN POSITION. THE PICC WAS ORIGINALLY PLACED JUST YESTERDAY. RN HAD TO OVERLINE EXCHANGE THE LINE CAUSING THE PT AN EXTRA PROCEDURE AND INFECTION RISK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875586 ↗