PowerMidline CK000727Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741138478), received between May 16, 2024 and Mar 17, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 16, 2026.

Recalls naming this device

1. May 21, 2026Open, Classified

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

   Z-2662-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Material Deformation

  IT WAS REPORTED THREE BARD SL POWER KITS WHERE THE TOP OF THE GRAY SHEATH OF THE INTRODUCER HAS A SMALL SPLIT APPROXIMATELY 1 CM IN LENGTH. THIS IS BEFORE USE. THERE WAS NO NEGATIVE OUTCOME THAT OCCURRED AS A RESULT. THIS REPORT ADDRESSES ALL THREE KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617548 ↗
• MalfunctionMar 17, 2026Material Deformation

  IT WAS REPORTED BARD SL POWER KIT WHERE THE TOP OF THE GRAY SHEATH OF THE INTRODUCER HAS A SMALL SPLIT APPROXIMATELY 1 CM IN LENGTH. THIS IS BEFORE USE. I NOTICED THE SPLIT UPON INSERTION WITH VERY LITTLE FORCE. NO NEGATIVE OUTCOME OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617536 ↗
• MalfunctionJun 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE HAVE BEEN SEVERAL REPORTS OF FIBERS ON THE WIRE. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132944 ↗
• MalfunctionApr 17, 2025Defective Component; Defective Component

  IT WAS REPORTED "I WAS PLACING A MIDLINE TODAY AND NOTICED A WEIRD SPIRALING ON THE INTERNAL WIRE FOR THE POWER MIDLINE. WHEN I PULLED THE WIRE OUT OF THE MIDLINE AFTER THE MIDLINE WAS PLACED, I NOTICED FRAYING ON THE WIRE ITSELF. YOU CAN SEE SOME SMALL WHITE SPECKS AND FRAYS. I THEN NOTICED IT ON MY SECOND MIDLINE OF THE DAY. A COLLEGE ASKED ME IF I WOULD BE ABLE TO PULL ANY OF THOSE PIECES OFF IF I GRABBED ON TO THEM. I TRIED THIS AFTER AND I HAD ONE THAT FLAKED OFF RIGHT IN MY HAND. JUST LOOKED LIKE A LITTLE WHITE SPECK. THE FRAYING DOES GET WORSE IF YOU RUN YOUR FINGERS ACROSS IT., IT'S WAY MORE NOTICEABLE AT THAT POINT. THERE WAS NO ADVERSE EVENT DURING OR AFTER THE PROCEDURE." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858491 ↗
• MalfunctionMay 16, 2024Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED, ¿THIS GUIDE WIRE DID NOT LOOK THIS WAY UNTIL AFTER I TRIED TO PUT IT IN THE PT., AT WHICH TIME I COULD NOT ADVANCE IT AND LITERALLY HAD TO FORCE IT OUT OF THE VEIN! THE VEIN WAS NO LONGER USABLE AFTER THAT. AFTER I FORCED THE GUIDE WIRE OUT, SHE DID HAVE SOME BLEEDING AND EXPRESSED SOME PAIN AT THE SITE, THE BLEEDING WAS EASILY CONTROLLED. IT DID LEAVE A VISIBLE HEMATOMA THAT RAPIDLY APPEARED, WHICH I NORMALLY DO NOT SEE IN MY PATIENTS, BUT AGAIN SHE WAS COMPROMISED, AND HER EXTREMITIES WERE COVERED WITH BRUISES.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19338029 ↗