PowerPICC Provena S3274108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741130403), received between Mar 19, 2018 and Jun 4, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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-2664-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionJun 4, 2021Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE STYLET UNRAVELED WHEN RETRACTING FROM PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938982 ↗
• MalfunctionApr 16, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PICC LINE GUIDEWIRE BECAME FRAYED AND ¿ELASTIC¿ WHEN REMOVED. THE WIRE WAS STILL IN TACT AND DID SAVE IT FOR EVALUATION, HOWEVER THE DEVICE WAS IN THE PATIENT. THEY PERFORMED X RAYS TO CONFIRM NOTHING RESIDED INSIDE THE PATIENT FROM THE PICC LINE INSERTION, THE PATIENT WAS FINE AND UNAFFECTED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680715 ↗
• MalfunctionJun 13, 2019Difficult to Flush; Material Twisted/Bent

  IT WAS REPORTED THAT THE PICC WAS PLACED 5/19 IN R BRACHIAL, LEFT AT 15 CM. REMOVED ON 5/20. THE TIP WAS NOT CONFIRMED IN CAJ AND LEFT AS A MIDLINE. NURSE COMPLAINED THAT IT WOULD NOT FLUSH SEVERAL HOURS AFTER INSERTION. PICC WAS REMOVED AND NOTICED TO BE BENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8697755 ↗
• MalfunctionMar 21, 2018Leak/Splash

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAS TWO 4 FR PROVENA CATHETERS THAT ARE LEAKING AT THE EXTENSION LEGS. NO OTHER INFORMATION WAS PROVIDED, BUT HAS BEEN REQUESTED. NO PATIENT INJURY REPORTED. THIS FILE IS FOR FIRST OF TWO EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7359186 ↗
• MalfunctionMar 21, 2018Fluid/Blood Leak

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAS TWO 4 FR PROVENA CATHETERS THAT ARE LEAKING AT THE EXTENSION LEGS. NO OTHER INFORMATION WAS PROVIDED, BUT HAS BEEN REQUESTED. NO PATIENT INJURY REPORTED. THIS FILE IS FOR THE SECOND OF TWO EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7359183 ↗
• MalfunctionMar 19, 2018Break; Fluid/Blood Leak

  THE SALES REP REPORTED THAT THE FACILITY HAD TWO CATHETERS BREAK AT THE EXTENSION LEG AND LEAK. NO OTHER INFORMATION WAS PROVIDED BUT HAS BEEN REQUESTED. THIS FILE IS FOR THE SECOND OF TWO EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7351002 ↗
• MalfunctionMar 19, 2018Break; Leak/Splash

  THE SALES REP REPORTED THAT THE FACILITY HAD TWO CATHETERS BREAK AT THE EXTENSION LEG AND LEAK. NO OTHER INFORMATION WAS PROVIDED BUT HAS BEEN REQUESTED. THIS FILE IS FOR THE FIRST OF TWO EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7350981 ↗