PowerPICC CK000821Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741152580), received between Aug 5, 2020 and Oct 10, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CT IV CONTRAST BOLUS EXTRAVASATED INTO LEFT ARM/AXILLA. ON REMOVAL HOLE NOTED AT 10 CM MARK. 4 FR CATHETER WOULD NOT ADVANCE SO WAS EXCHANGED FOR 3 FR CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423458 ↗
• MalfunctionJun 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT ARRIVED TO EMERGENCY DEPARTMENT COMPLAINING OF PICC LINE LEAKING; DRESSING TAKEN DOWN & LINE FLUSHED. LEAKING NOTED AT THE JUNCTION OF THE EXTENSION TUBING AND LUMEN. INDENTATION FROM CLAMP NOTED. POSSIBLE OVERUSE OF CLAMP AT LOCATION DISRUPTED TUBING INTEGRITY. NOTHING WAS INFUSING AT TIME OF LEAK DISCOVERY. INSERTED AC, SECURED WITH STATLOCK. PICC D/C'D. PIV ESTABLISHED TO BRIDGE, PICC SCHEDULED TO BE REPLACED 5/30. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630638 ↗
• MalfunctionJul 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VAT WAS CALLED URGENTLY TO ASSESS LEAKING PICC. NOTED HOLE IN THE "PIGTAIL" PORTION OF THE PICC, CLOSE TO THE HARD PLASTIC PIECE THAT CONNECTS TO THE NEEDLELESS CONNECTOR. UNDERWENT AT LEAST 10 ADDITIONAL STICKS UNTIL NEW PICC WAS PLACED BETWEEN IV ACCESS AND LAB DRAWS. DEVICE WAS PLACED 3CM BELOW THE KNEE, AND NEONATAL GRIPLOCK WAS USED TO SECURE. PATIENT WAS BEING TREATED FOR S/P ENTEROPLASTY AND REDO ILEOCOLIC ANASTOMOSIS, AND HAS A HISTORY OF OMPHALOCEALE WITH JEJUNAL ATRESIA. INFUSING: D5 77 NS 77 ACETATE AT 5 CC HR, HEP FLUSH 5/28 18:57. (LAST 7 DAYS REVIEWED) CEFEPIME 40MG Q 8 LAST DOSE 5/26 21:58, VANCOMYCIN 160 MG Q 6 LAST DOSE 5/26 18:19, TPA 5/26 23:36 BY VAT. LINE FLUSHED BUT DID NOT HAVE BLOOD RETURN ONLY ONE DOSE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312983 ↗
• MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A 3 FR CATHETER PLACED IN FEBRUARY SPRUNG A LEAK AT THE CONNECTION BETWEEN THE HUB AND THE EXTERNAL LUMEN. THE LINE HAD TO BE REPLACED. ADDITIONAL INFORMATION RECEIVED ON 4/12/2023: IT WAS REPORTED THAT ON (B)(6) AT 2030 FLUID WAS NOTED BY BEDSIDE NURSE AND CONFIRMED BY VAT. CATHETER WAS REMOVED. NEW PICC PLACED (B)(6) 2023. PATIENT UNABLE TO RECEIVE CPN FOR 2 DAYS UNTIL NEW LINE PLACED. CATHETER WAS SECURED WITH SECUREACATH. NO PATIENT HARM OR SYMPTOMS RELATED TO THE FLUID LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792383 ↗
• MalfunctionFeb 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT, 3FR SV REPORTED TO HAVE HOLE IN IT. PICC FOUND LEAKING WHERE THE PURPLE HUB ATTACHES TO THE EXTERNAL LUMEN. SECURACATH WAS USED AS THE CATHETER SECUREMENT. PATIENT NEEDED ANOTHER PICC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439749 ↗
• MalfunctionAug 5, 2020Material Frayed; Material Frayed

  IT WAS REPORTED YESTERDAY THE TEAM WAS INSERTING A 3 FR SINGLE LUMEN PICC FOR A 5 YEAR OLD, AT THE END OF THE PROCEDURE WHEN THE GUIDE WIRE WAS BEING REMOVED FROM THE CATHETER, IT WAS NOTED THAT THE GUIDEWIRE WAS FRACTURED APPROXIMATELY 5 CM FROM THE TIP AND WAS DANGLING. THE WIRE HAD BEEN WITHDRAWN AND THE CATHETER WAS TRIMMED PRIOR TO THE PROCEDURE. THE INSERTER IS 100% CERTAIN THAT THE GUIDEWIRE WAS WITHDRAWN WELL PAST THE TRIM SITE. THE INSERTION WAS UNEVENTFUL, HOWEVER THE 3CG WAS NOT READING CORRECTLY AND A CHEST X-RAY WAS OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370935 ↗