PowerPICC CK000822Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741152597), received between Oct 9, 2019 and Feb 9, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionFeb 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "RN REPORTED DIFFICULTY OBTAINING LABS. UPON REMOVAL OF DRESSING, CATHETER NOTED TO BE KINKED AT INSERTION SITE AT A 90 DEGREE ANGLE. ONCE LINED STRAIGHTENED, BLOOD WAS NOTED TO BE LEAKING FROM SOMEWHERE ON EXPOSED ASPECT OF CATHETER. A HOLE WAS THEN NOTED TO BE PRESENT ON UNDERSIDE OF CATHETER JUST PAST THE HUB¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16345164 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT 4FR DOUBLE SV POWERPICC BROKE POST INSERTION. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2022 IT WAS STATED THAT THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972348 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT 4FR DOUBLE SV POWERPICC BROKE POST INSERTION. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2022 IT WAS STATED THAT THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972257 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED THAT 4FR DOUBLE SV POWERPICC BROKE POST INSERTION. NO OTHER INFORMATION WAS PROVIDED. 03/11/2022-IT WAS STATED THAT THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972032 ↗
• MalfunctionFeb 24, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT 4FR DOUBLE SV POWERPICC BROKE POST INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595402 ↗
• MalfunctionOct 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 4 FR DUAL LUMEN PICC LEAKED AT THE JUNCTION OF THE CATHETER TUBING TO THE HUB. IT WAS STATED THE CATHETER HAD BEEN IN PLACE LESS THAN TWO WEEKS AND PATIENT WAS IN-HOUSE SO FACILITY WAS PROVIDING PICC MAINTENANCE. (B)(6) 2019: ADDITIONAL INFORMATION: 31 CM TOTAL LENGTH WITH 2 CM EXTERNAL SEGMENT. SECURACATH FOR SECUREMENT. PATIENT WAS HOSPITALIZED FOR THE ENTIRE PERIOD OF TIME. DRESSINGS MANAGED BY VASCULAR ACCESS TEAM. LINE USE HISTORY: (B)(6) - 1155 AND 1157 ALTEPLASE ORDERED ¿ CATHETER CLEARED. (B)(6) - 1952 LUMEN 2 (RED) WITH POSITIVE BLOOD RETURN PRIOR TO INJECTION ¿ POWER INJECTED WITH IODIXANOL 320 MG IODINE/ML (VISIPAQUE) 50 ML ¿ POSITIVE BLOOD RETURN FOLLOWING INJECTION ¿ SALINE FLUSHED/LOCKED. (B)(6) INTERVENTIONAL RADIOLOGY PROCEDURE FOR BILIARY STENT PLACEMENT AND LIVER BIOPSY ¿ CATHETER LIKELY UTILIZED BY ANESTHESIA STAFF. (B)(6) - 1800 LIPID INFUSION STARTED. (B)(6) - 1300 NO BLOOD RETURN ¿ FRESH DRESSING NOTED TO HAVE BLOOD TINGED FLUIDS AND LEAKED AT THE JUNCTION OF THE CATHETER AND THE HUB WHEN FLUSHED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9173543 ↗