PowerPICC Provena CK000886Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741188831), received between Feb 28, 2020 and Apr 19, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "THE LINE BROKE UNDER DRESSING, IT APPEARS ONE OF THE EXTERNAL LUMENS WAS CUT OR BROKE WHILE LINE WAS DWELLING." ADDITIONAL INFORMATION RECEIVED 4/11/2023: "CATHETER BREAK DISCOVERED AS CATHETER LEAKING WHEN FLUSHED. BREAK WAS EXTERNAL TO THE PATIENT, NO PIECES RETAINED IN PATIENT. EVENT WAS NOT AN URGENT/LIFE THREATING MEDICAL SITUATION. PICC HAD TO BE REPLACED, NO OTHER NEGATIVE IMPACT TO PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769719 ↗
• MalfunctionNov 18, 2021Component Incompatible; Component Incompatible

  IT WAS REPORTED "I PLACED A PICC AND THE INTRODUCER WOULD NOT STAY SCREWED TOGETHER (INNER AND OUTER PIECE). I STRUGGLED WITH IT POPPING OFF WHEN I WAS TRYING TO PUT INTRODUCER IN, AND THEN THE OUTER PART FISH MOUTHED BECAUSE OF IT. I DID NOT SAVE THE INTRODUCER." ADD INFO RCVD 11/03/2021: PLACEMENT INFO: RIGHT BRACHIAL VEIN PICC PLACEMENT. OPENED NEW INTRODUCER KIT TO OBTAIN NEW INTRODUCER. PLACEMENT SUCCESSFUL. WAS THERE PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839896 ↗
• MalfunctionOct 2, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED PRIOR TO PLACING THE PICC LINE, HEALTH PROFESSIONAL NOTED THAT THE GREY PORT WAS SPLIT ON THE SIDE AND WAS LEAKING FLUID.

  Patient problems: No Patient Involvement

  MAUDE report 10620756 ↗
• MalfunctionFeb 28, 2020Material Deformation; Material Deformation

  IT WAS REPORTED "DURING PICC INSERTION, VESSEL WAS ACCESSED WITH STEEL NEEDLE, INTRODUCER WIRE WAS DEPLOYED AND ADVANCED APPROXIMATELY 10CM. UPON FAILURE TO ADVANCE FURTHER, THE INSERTING NURSE ATTEMPTED TO REMOVE THE STEEL NEEDLE ALONG WITH THE INTRODUCER WIRE SIMULTANEOUSLY. THE INTRODUCER WIRE WOULD NOT COME OUT, SO THE STEEL NEEDLE WAS REMOVED AND THE WIRE COULD NOT BE REMOVED. VASCULAR SURGERY WAS CONSULTED AND THE WIRE WAS SUCCESSFULLY REMOVED BY THE SURGEON BY APPLYING INCREASED TRACTION ON THE WIRE. THE WIRE IS INTACT BUT THE TIP IS BENT AT A 90 DEGREE ANGLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9769904 ↗