PowerPICC CK000775ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741188060), received between Apr 8, 2020 and Apr 14, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 11, 2025Open, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Difficult or Delayed Separation

  IT WAS REPORTED THAT A DILATOR CAME APART IN CCF'S 4FR SINGLE LUMEN PICC KIT. NO HARM TO THE PATIENT OR CLINICIAN WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873088 ↗
• MalfunctionOct 21, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED AFTER THE PICC WAS THREADED THROUGH THE DILATOR AND IN CORRECT POSITION - I WENT TO CRACK THE DILATOR TO REMOVE THE PEEL AWAY SHEATH, HALF OF THE ORANGE PEEL AWAY TAB SEPARATED FROM THE DEVICE. IT JUST DID NOT CRACK CLEANLY TO PEEL AWAY. IT CRACKED AND CAME OFF - A SMALLER PIECE STAYED ATTACHED TO THE OTHER HALF OF THE TAB ON THE OTHER SIDE MAKING IT DIFFICULT TO REMOVE. HAD TO PICK AT IT TO GET IT OFF PICC AND PULL PICC PART WAY OUT. THE PROCEDURE TOOK A LONGER TIME DUE TO DIFFICULTY REMOVING PEEL AWAY AND HAVING TO PULL PICC PART WAY OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351472 ↗
• MalfunctionNov 22, 2024Misassembled; Activation Problem; Misassembled; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A DEFECTIVE SAFETY ON A NEEDLE USED FOR LIDOCAINE INJECTIONS IN A PICC KIT. IT SEEMS TO BE MISSING THE PIECE THAT PULLS OVER THE TIP OF THE NEEDLE. AS IS SUCH, THE SAFETY CANNOT BE DEPLOYED BECAUSE IT DOES NOT EXIST. THE DEFECT WAS OBSERVED AFTER OPENING THE PICC KIT, AND BEFORE UTILIZING THE NEEDLE FOR PATIENT USE. THERE WAS NO IMPACT TO THE PATIENT AND NO ADVERSE OR SERIOUS EVENT OCCURRED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20762533 ↗
• MalfunctionOct 25, 2024Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT SEPTUM ON THE PICC WHERE THE WIRE GOES THROUGH IS DIMPLED INSTEAD OF FLAT. THE WIRE IS SLIDING IN AND OUT VERY EASILY WHEN PLACING THE PICC WHICH IT DIDN¿T BEFORE. THERE WAS NO PATIENT HARM DUE TO THE ISSUE WITH THE SEPTUM. IT DID TAKE MORE TIME TO COMPLETE THE PICC INSERTION AS THE GUIDE WIRE WOULD SLIP IN AND OUT OF THE SEPTUM. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537347 ↗
• MalfunctionSep 26, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT USER HAD THEIR PPE ON AND WHEN THEY WENT TO GO INTO THE PICC TRAY THEY FOUND A HAIR UNDERNEATH THE DRAPE IN THE KIT. HAD TO OPEN ANOTHER KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311608 ↗
• MalfunctionJul 25, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED, THERE HAVE BEEN COMPLAINTS FROM OUR TEAM REGARDING THE PEEL AWAY SHEATH AND NOT COMPLETELY SEPARATING WHEN IT WAS SUPPOSED TO. MOST RECENTLY, THE SHEATH WOULD NOT SEPARATE AT THE ORANGE ASPECT OF THE SHEATH. THE PROCEDURALIST THOUGHT THEY WERE GOING TO HAVE TO INSERT THE INTRODUCER AND REMOVE BOTH COMPONENTS COMPLETELY. WE WOULD NOT RECOMMEND USING SCISSORS BUT IT WAS DESCRIBED TO ME THAT THE PROCEDURALIST FELT THEY NEEDED SCISSORS IN ORDER TO SEPARATE THE COMPONENTS OF THE PEEL AWAY SHEATH. THIS IS HOW DIFFICULT IT WAS TO SEPARATE. THERE WERE DELAYS DURING THE PROCEDURE AS A RESULT. THE PATIENT HAD THE SHEATH IN LONGER THAN NEEDED. NO INJURY WAS REPORTED TO THE PATIENT OR HEALTHCARE PROFESSIONAL. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824534 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, "SITUATION WHERE THE PATIENT COMPLAINED OF FEELING HOT AND THEN DEVELOPED RED BLOTCHY SKIN AND HIVES IMMEDIATELY FOLLOWING THE PICC PLACEMENT. THE PICC POSITION WAS CONFIRMED VIA THE SHERLOCK 3CG TIP LOCATION SYSTEM. THE PATIENT THEN BECAME UNRESPONSIVE AND A CODE BLUE WAS INITIATED. ONCE ROSC WAS ACHIEVED THE PICC WAS REMOVED IMMEDIATELY AND THE PATIENT'S CONDITION BEGAN IMPROVING."

  Patient problems: Cardiac Arrest; Urticaria

  MAUDE report 17007197 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED: OUR TEAM INSERTED A BARD 4FR SINGLE LUMEN PICC IN A PATIENT. UNFORTUNATELY, THE PATIENT DID SUFFER FROM AN AIR EMBOLISM SECONDARY TO THE PICC LINE. THE PICC LINE WAS REMOVED AS THE INTEGRITY OF THE LINE WAS IN QUESTION AS A RESULT OF THE CLINICAL OUTCOME OF THIS PATIENT.

  Patient problems: Embolism/Embolus

  MAUDE report 16904582 ↗
• MalfunctionJan 13, 2023Activation Problem; Activation Problem

  IT WAS REPORTED "A PICC INSERTION NEEDLE GREEN PROTECTIVE COVER DID NOT ENGAGE CORRECTLY. IT SLIPPED RIGHT OFF THE END OF THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161170 ↗
• MalfunctionMay 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THIS MORNING WE DID A PICC EXCHANGE AND FOUND THAT THE OLD CATHETER WAS FRACTURED INSIDE THE PATIENT¿S ARM." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11872902 ↗
• MalfunctionFeb 10, 2021Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED WHEN THE KIT WAS OPENED, A HAIR (LONG AND LIGHT COLORED) WAS ON TOP OF THE CATHETER PORTION OF THE KIT. THE LOT REEW3112.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11308728 ↗
• MalfunctionMay 29, 2020Material Deformation; Material Deformation

  IT WAS REPORTED "THE DILATOR FRAYED." ON 05/13/2020: ADDITIONAL INFORMATION RECEIVED: PICC PLACED IN RIGHT BASILIC VEIN. UNABLE TO INSERT DILATOR OVER GUIDEWIRE. WITHDREW THE DILATOR TO NICK PATIENT'S SKIN TO ASSIST IN PLACEMENT OF DILATOR. UPON ASSESSING DILATOR, IT WAS FRAYED AT THE END IN SEVERAL LOCATIONS. NEW DILATOR DROPPED ONTO STERILE FIELD AND INSERTED OVER GUIDEWIRE WITHOUT ISSUE. AFTER COMPLETION OF PROCEDURE, PICTURES TAKEN OF FRAYED DILATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102147 ↗
• MalfunctionApr 15, 2020Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "WE HAD A DILATOR IN THE CUSTOM KIT WITH SHARP EDGES ON IT. WHEN THE INSERTER TRIED TO BREAK THE DILATOR SHE WAS ¿POKED¿ BY SOMETHING RAZOR SHARP. UPON ASSESSMENT IT WAS NOTICED THAT THE DILATOR HAD A PIECE OF PLASTIC STICKING STRAIGHT UP WHERE THE BARD IMPRINT IS ON THE DILATOR. THE INSERTER CHANGED HER GLOVES AS A PRECAUTION HOWEVER IT IS UNKNOWN IF IT PIERCED THE SKIN." 03/26/2020- ADDITIONAL INFORMATION RECEIVED STATED, "CAREGIVER EXPERIENCED A SHARP SENSATION ON HER THUMB. IT WAS OBSERVED THAT THERE WAS A DEFECT IN THE PEEL AWAY SHEATH HANDLE AS A SHARP PIECE OF PLASTIC WAS NOTED NEAR THE ¿BARD¿ LABEL." (B)(6) 2020- NO PROPHYLACTIC THERAPY WAS REPORTED.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 9962606 ↗
• MalfunctionApr 8, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE ULTRASOUND PROBE COVER LOCATED INSIDE THE KIT HAD A SMALL HOLE IN IT CAUSING GEL TO LEAK.

  Patient problems: No Patient Involvement

  MAUDE report 9937632 ↗