PowerPICC® SV Catheter 3274108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741027833), received between Nov 6, 2018 and Feb 19, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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.

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.

• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PICC FRACTURE/LEAKING. ADDITIONAL INFORMATION RECEIVED 02/07/2025: IT WAS REPORTED PATIENTS' PICC HAD TO BE REMOVED AND ANOTHER PICC WAS INSERTED. ADDITIONAL INFORMATION RECEIVED ON 02/13/2025: IT WAS REPORTED THE LEAK WAS EXTERNAL TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411884 ↗
• MalfunctionApr 5, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE PICC WIRE GOT STUCK AFTER INSERTION. WHEN REMOVED NOTICED THEN THE TIP OF THE WIRE HAD A KNOT IN IT. ANESTHESIA USED A PICC LINE AND IT ENDED UP WITH A KNOT IN IT. SHE USED ANOTHER ONE AND IT WAS FINE. IT WAS A SEASONED ANESTHESIA PERSON AND SHE SAID HAD NEVER SEEN IT. PROVIDER SAID SHE INSERTED THE WIRE THROUGH THE NEEDLE, AND IT WOULDN'T THREAD INTO THE VEIN SO SHE TRIED TO REMOVE IT AND IT WOULDN'T COME OUT. IT WAS LIKE STUCK IN THERE. SO THEY ASKED FOR AN XRAY AND IT WAS IN THE SUBCUTANEOUS TISSUE AND AT THAT POINT IN TIME SHE MADE A WIDER EXCISION IN THE SKIN AND THEN APPLIED SOME SIGNIFICANT TRACTION AND WAS ABLE TO REMOVE. NOTICED THEN THE TIP OF THE WIRE HAD A KNOT IN IT. SHE ONLY HAD MADE ONE ATTEMPT WITH THAT ONE, THEN GOT A NEW KIT, SWITCHED ARMS AND WAS ABLE TO GET IT IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056309 ↗
• MalfunctionJun 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC WAS CRACKED DUE TO PATIENT MOVING AROUND AND CONTORTION." ADD INFO RCVD 05/17/2022: A DETAILED DESCRIPTION OF THE EVENT: PICC LINE PLACED (B)(6), CUT AT 35 CM TOTAL EXTERNAL LENGTH WAS 3 CM, SECURACATH 4 FR PLACED ON LINE FOR SECUREMENT, STAT LOCK ALSO PRESENT TO HOLD IN PLACE. LINE WAS REPORTED AS UNABLE TO FLUSH, CATHFLO WAS USED, WHILE ADMINISTERING CATHFLO DRESSING NOTED TO BE INCREASINGLY WET. DRESSING REMOVED, SITE INSPECTED, LINE AGAIN FLUSHED AND NOTED FLUID LEAKING OUT OF THE CATHETER AT 3CM THE PICC LINE HAD SPLIT. CATHETER REMOVED (B)(6) 2022. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? SECURACATH ONLINE AND, STAT LOCK HOLDING HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566366 ↗
• MalfunctionNov 6, 2018Material Deformation

  IT WAS REPORTED DURING INSERTION OF THE PICC LINE THE RN NOTED THE WIRE WAS KINKED AT THE TIP. ANOTHER SET KIT WAS OPENED AND USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8044283 ↗