PowerPICC® Catheter 3174108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741027581), received between Jan 4, 2019 and Jun 10, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 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. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE GUIDEWIRE SHREDDED AND THE INSERTION WAS ABORTED. X-RAY CONFIRMED NOTHING WAS LEFT OVER. NO ADVERSE EVENT OR HARM TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505098 ↗
• MalfunctionJan 19, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT A DEFECTIVE PIECE OF EQUIPMENT FROM PICC KITS? WE HAVE A FRAYED STYLET WIRE FROM THE 4FR SL PICC KIT, VERY STRANGE OCCURRENCE. WIRE FRAYED, UNSURE OF PATIENT IMPACT AT THIS TIME. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545910 ↗
• InjuryNov 7, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY MEDWATCH "PATIENT HAD PICC LINE INSERTED. NOTED GUIDEWIRE ON CHEST X-RAY 3 WEEKS LATER, NECESSITATED REMOVAL. DEVICE FAILED."

  Patient problems: Foreign Body In Patient

  MAUDE report 15748444 ↗
• MalfunctionOct 27, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE POWERPICC FULL FRENCH GUIDEWIRE FRACTURED AND NEEDED TO BE REMOVED. CUSTOMER STATED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681374 ↗
• MalfunctionOct 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MS&S "TECHNICIAN REQUESTING RECOMMENDATIONS ON POWER INJECTING A PATIENT'S 4F SINGLE LUMEN POWERPICC ((B)(4)). STATES THEY HAD A FEW INSTANCES WHEN THE POWER INJECTOR "POPS OFF" THE PATIENT'S POWERPICC WHEN PERFORMING A POWER INJECTION OF CT CONTRAST. THEY ARE NOT SURE IF THEY ARE DOING SOMETHING WRONG AND BELIEVES THIS IS USER ERROR. ALSO, REQUESTING FOR SOMEONE TO COME IN AND PERFORM ANOTHER IN SERVICE. STATES THEY ARE POWER INJECTING AT A MAX FLOW RATE OF 3-4ML/SEC." MS&S RESPONSE "DISCUSSED THE POWERPICC IFU. INQUIRED IF THEY ARE REMOVING THE NEEDLELESS CONNECTOR PRIOR TO POWER INJECTING. CUSTOMER STATES SHE IS UNSURE. CUSTOMER STATES THEY ARE ATTACHING A 10ML NORMAL SALINE SYRINGE, ASPIRATING BLOOD AND THEN FLUSHING 10ML OF NORMAL SALINE. INQUIRED IF THEY ARE WARMING THE CT CONTRAST TO BODY TEMPERATURE. CUSTOMER STATES THEY ARE WARMING THE CT CONTRAST" ADDITIONAL INFO. RECEIVED 09/23/2021: "THERE WAS NOTHING WRONG WITH THE KIT OR THE POWER PICC. THE RADIOLOGY STAFF DOES NOT HAVE A LOT OF TRAINING REGARDING THE POWER INJECTOR AND POWER PICCS. NURSING ACCESS THE POWER PICC FOR US. SINCE WE WERE HAVING ISSUES WITH THE TUBING NOT STAYING IN TACT FROM INJECTOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577956 ↗
• MalfunctionMay 5, 2020Defective Component; Defective Component

  IT WAS REPORTED "GLASS PIECE WAS FOUND IN THE BLUE WRAPPER AND IN THE CONTAINER OF THE PRODUCT."

  Patient problems: No Patient Involvement

  MAUDE report 10026634 ↗
• MalfunctionJul 26, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE SETTING UP TRAY GUIDEWIRE SEPARATED. GUIDEWIRE IS PULLED BACK FROM END OF CATHETER THROUGH A RUBBER STOPPER AND WHEN IT WAS PULLED IT APPEARED TO SEPARATE TO AN INNER AND OUTER PIECE. NEW CATHETER FROM DIFFERENT LOT # USED FOR PATIENT WITHOUT INCIDENT. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8831511 ↗
• MalfunctionMar 8, 2019Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD THE PICC FOR 5 WEEKS. WHEN PATIENT RECEIVED A DOSE OF VANCOMYCIN, A LEAK IN THE PICC WAS OBSERVED AND A PINHOLE WAS FOUND IN THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8404015 ↗
• MalfunctionJan 4, 2019Material Puncture/Hole

  IT WAS REPORTED A HOLE WAS FOUND IN THE PICC AND PATIENT WAS EXPOSED TO CONTRAST DYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Chemical Exposure

  MAUDE report 8220060 ↗