PowerPICC Provena S1275108FD2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741154850), received between Nov 11, 2020 and Feb 22, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionFeb 22, 2023Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED, CRACK IN CLEAR T-PORT WHICH IS WHAT THE STYLET GOES THROUGH, PICC HAD TO BE EXCHANGED FOR A NEW ONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16425152 ↗
• MalfunctionMay 13, 2022Component Incompatible; Contamination /Decontamination Problem; Component Incompatible; Contamination /Decontamination Problem

  IT WAS REPORTED "I COULDN¿T PASS THE GUIDE WIRE THROUGH THE NEEDLE WITH THE BLUE ARROW TO IT. IF YOU LOOK WHERE THE BLUE ARROW IS COMPARED TO THE ONE THAT WORKED, THERE IS A LARGE METAL PIECE (OR SOMETHING SIMILAR). THAT IS WHERE THE GUIDE WIRE WOULD NOT PASS AT." ADDITIONAL INFO. RECEIVED 04/28/2022: WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399972 ↗
• MalfunctionMar 11, 2022Activation, Positioning or Separation Problem

  ELDERLY FEMALE WITH RECENT HISTORY OF URINARY TRACT INFECTION (UTI) AND SEPSIS. PROCEDURE: WHILE THE IV TEAM WAS INSERTING A PICC LINE, THE GUIDEWIRE WOULD NOT THREAD THROUGH THE NEEDLE. NEEDLE PULLED OUT AND ANOTHER ONE USED SUCCESSFULLY. WHEN THE ORIGINAL NEEDLE WAS EXAMINED OUTSIDE OF THE PATIENT, THE GUIDEWIRE STILL WAS NOT ABLE TO BE THREADED IN. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS, POWERPICC PROVENA (PER SITE REPORTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13731726 ↗
• MalfunctionNov 11, 2020Output Problem

  IT WAS REPORTED "IN 4-5 OF THE PICC KIT THE 3CG WIRE SEEMS TO BE FAULTY BECAUSE THE TRACKING IS VERY INTERMITTENT AND UNRELIABLE." THIS REPORT ADDRESSES THE THIRD OF FIVE KITS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823044 ↗
• MalfunctionNov 11, 2020Electrical /Electronic Property Problem

  IT WAS REPORTED "IN 4-5 OF THE PICC KIT THE 3CG WIRE SEEMS TO BE FAULTY BECAUSE THE TRACKING IS VERY INTERMITTENT AND UNRELIABLE." THIS REPORT ADDRESSES THE FIFTH OF FIVE KITS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823043 ↗
• MalfunctionNov 11, 2020Electrical /Electronic Property Problem

  IT WAS REPORTED "IN 4-5 OF THE PICC KIT THE 3CG WIRE SEEMS TO BE FAULTY BECAUSE THE TRACKING IS VERY INTERMITTENT AND UNRELIABLE." THIS REPORT ADDRESSES THE FOURTH OF FIVE KITS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823042 ↗
• MalfunctionNov 11, 2020Sensing Intermittently

  IT WAS REPORTED "IN 4-5 OF THE PICC KIT THE 3CG WIRE SEEMS TO BE FAULTY BECAUSE THE TRACKING IS VERY INTERMITTENT AND UNRELIABLE." THIS REPORT ADDRESSES THE SECOND OF FIVE KITS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10822970 ↗
• MalfunctionNov 11, 2020Sensing Intermittently

  IT WAS REPORTED "IN 4-5 OF THE PICC KIT THE 3CG WIRE SEEMS TO BE FAULTY BECAUSE THE TRACKING IS VERY INTERMITTENT AND UNRELIABLE." THIS REPORT ADDRESSES THE FIRST OF FIVE KITS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10822957 ↗