PowerPICC CK000819Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741152566), received between Mar 1, 2023 and Jan 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, "MOM UNABLE TO FLUSH PICC AT HOME. DRESSING CHANGED 2 DAYS PRIOR TO ISSUE BUT USED YESTERDAY WITHOUT ISSUES. 2 DOSES OF TPA UNSUCCESS FOR BRISK BLOOD RETURN (ABLE FLUSH AFTER FIRST DOSE). X-RAY SHOWED CATHETER IS NOW BRACHIOCEPHALIC (POSSIBLE KINK IN ARM). CATHETER REMOVED AND NEW LINE PLACED. CATHETER SECURED WITH SECURACATH, 14CM ABOVE ANTECUBITAL FOSSA, 5CM EXTERNAL. PLACED ON (B)(6) 2024 AND REMOVED ON (B)(6) 2024. PATIENT REQUIRED ED VISIT OVER THE WEEKEND. FORTUNATELY, WE WERE ABLE TO REPLACE IN THE ED AND DID NOT REQUIRE AN ADMISSION. CATHETER REMOVED AND NEW LINE PLACED. NO PATIENT HARM REPORTED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148100 ↗
• MalfunctionSep 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT 4 FR SINGLE LUMEN PICC RUPTURE AT 40CM MARK. RUPTURE FOUND ON LINE REMOVAL THERAPY NO LONGER NEEDED. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFO FROM CUSTOMER: ((B)(6) 2023) CATHETER WAS REMOVED (B)(6) 2023 NO NEW CATHETER PLACED AS THERAPY COMPLETE. PATIENT MENTIONED TO NURSE REMOVING THE LINE THAT SHE HAD A LOT OF ISSUES WITH IT SO RN CLOSELY INSPECTED CATHETER AND FOUND RUPTURE AT 40 CM MARK. IT WAS SECURED WITH SECUR-A-CATH. NO PT HARM REPORTED. WAS BEING TREATED FOR PERSISTENT HEADACHES AND DOUBLE VISION ADJUSTMENT OF PROGRAMMABLE SHUNT. THEY DO NOT HAVE AN INFECTION DISEASE. UNKOWN WHEN CATHETER RUPTURE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17752916 ↗
• MalfunctionMar 28, 2023Material Discolored; Defective Component; Material Discolored; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, "BROWN DISCOLORATION AFTER USING SCISSORS. THE DISCOLORATION ON THE RING DISAPPEARED WITHIN A COUPLE HOURS. WHILE TRIMMING STATSEAL DISC BROWN DISCOLORATION WAS NOTED TO COME OFF SCISSORS. NEW RING AND SCISSORS OBTAINED BUT PICC HAD ALREADY BEEN PLACED AND SCISSORS USED TO TRIM CATHETER. STATLOCK WAS USED TO SECURE PICC. NO ISSUES AS OF 3/8/2023 WILL CONTINUE TO MONITOR. THERE WAS NO CONCOMITANT THERAPY AS EVENT OCCURRED WITH PICC PLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632026 ↗
• MalfunctionMar 1, 2023Material Discolored; Material Discolored

  IT WAS REPORTED BY THE CUSTOMER THAT "SOME SCISSORS FROM THE KIT THAT LEFT DISCOLORATION ON THE STAT SEAL DISC WHEN IT WAS TRIMMED. " ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: "THE DISCOLORATION WAS BROWN. A NEW DISC AND SCISSORS WERE OBTAINED BUT PICC HAD ALREADY BEEN PLACED AND THE SCISSORS WERE USED TO TRIM CATHETER. PATIENT IS BEING MONITORED FOR POTENTIAL COMPLICATIONS. PATIENT IS BEING TREATED FOR MSSA BACTEREMIA AND PULMONARY VALVE ENDOCARDITIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461378 ↗
• MalfunctionMar 1, 2023Failure to Infuse; Material Deformation; Failure to Infuse; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "12/22/2022 PT REPORTED THAT HER PICC WOULD OCCLUDE FREQUENTLY AND THAT SHE WOULD HAVE TO ADDUCT HER RIGHT ARM WHILE KEEPING THE PALMS UP TOWARDS THE CEILING. DRESSING CHANGED RN STARTED NS BOLUS AND NO ISSUES OBSERVED. 12/29 REPORTS PICC OCCLUSION ISSUES. X-RAY REQUESTED. ATTEMPTED PULLING LINE BACK TO ELIMINATE LOOP X 2. PICC WAS REMOVED ON (B)(6) AND NEW PICC ORDER PLACED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461011 ↗