PowerPICC CK000632BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741143755), received between Sep 12, 2018 and Jan 18, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CLINICIAN "I ACCESSED THE VEIN WITH THE NEEDLE. HAD BLOOD DRIPPING OUT OF IT. STARTED TO PUT THE WIRE IN. COULD FEEL IT LIKE DRAGGING AGAINST THE NEEDLE GOING IN, THAT FEEL ALWAYS TELLS ME I¿M IN THE VEIN. STARTED ADVANCING THE WIRE, IT STOPPED. SO I TRIED PULLING THE WIRE OUT, WOULD NOT COME OUT. THOUGHT IT MAY BE CAUGHT ON THE NEEDLE TIP SO I PULLED THE NEEDLE AND THE WIRE, NEEDLE CAME OUT, WIRE STAYED IN. THE PA CALL THE SURGEON HE SAID ANCHOR IT AND PUT BACITRACIN ON IT, HE¿LL TAKE CARE OF IT IN THE MORNING. WHILE THEY WERE GETTING THINGS I WAS PULLING BACK GENTLY AND I FELT IT GIVE, THOUGH I HAD IT. LOOKED UNDER MY GAUZE AND THAT¿S WHAT I SAW, IT COMPLETELY UNCOILED. THE PATIENT IS GOING TO OR TO HAVE IT REMOVED AND HAVE A CENTRAL LINE PLACED. I ASKED IF PATIENT MOVED OR HAD FLABBY ARMS. ANSWER - NO DIDN¿T MOVE THAT I COULD TELL, FIRMER ARM. NO THIS FELT LIKE IT WAS GOING IN THE VEIN. USUALLY IF IT¿S IN THE TISSUE CAN SE THE SKIN MOVEMENT. I WATCH FOR THAT TOO THE WIRE WAS REMOVED. THE REPORT INDICATED THE WIRE WAS IN THE VEIN, AND IT UNCOILED ON THE WAY IN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16200269 ↗
• MalfunctionJan 13, 2023Component Missing; Component Missing

  IT WAS REPORTED BY THE CUSTOMER THAT "THE KIT, WHEN OPENED, THE ACCESS NEEDLE WAS LAYING OUTSIDE OF THE TRAY WITH NO CAPTOR SAFETY PUTTING THE CLINICIAN AS WELL AS THEIR TECH AT RISK FOR A NEEDLE STICK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162692 ↗
• MalfunctionNov 30, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THEY WERE PLACING A 5 FR DL POWERPICC AND WHEN TRYING TO PUT INTRODUCER/DILATOR IN, IT "FELT LIKE IT MUSHROOMED OUT," IT WAS DIFFICULT TO PLACE. ADDITIONAL INFORMATION RECEIVED: THE CATHETER WAS SECURED WITH STATLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885918 ↗
• MalfunctionSep 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY HEALTH PROFESSIONAL "WE HAD AN INTERESTING EVENT ON (B)(6) 2021. ONE OF OUR NURSES WAS PLACING A PICC AND IT DIDN¿T FEEL RIGHT. SHE ATTEMPTED TO REMOVE IT AND IT KNOTTED INSIDE OF THE PATIENT. THE PATIENT HAD TO BE TRANSFERRED TO A LARGER HOSPITAL FOR PICC REMOVAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456792 ↗
• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT HEALTH PROFESSIONAL SAID WHEN HE WENT TO FLUSH THE LINE HE GOT SQUIRTED AND THE TUBING WAS CUT ON T-CONNECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757021 ↗
• MalfunctionApr 16, 2021Defective Component; Defective Component

  IT WAS REPORTED "PLACING A PICC ON (B)(6) 2021 AND NOTED THAT THE CLAMP AND TOP OF THE PICC WERE MALFORMED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679322 ↗
• MalfunctionSep 12, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PICC KIT WAS OPENED AND THERE WAS A FLY INSIDE. IT WAS NOT USED.

  Patient problems: No Information

  MAUDE report 7871027 ↗