PowerPICC SOLO CK000827Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741152610), received between Nov 9, 2018 and Dec 4, 2019 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2019Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED THAT A PATIENT WAS HAVING A PICC LINE 4FR INSERTED WHEN A SMALL FRACTURE MARK WAS NOTICED ON THE PICC LINE NEAR 3 CM MARK ON THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9411408 ↗
• MalfunctionDec 4, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN. IT WAS STATED THE PICC WAS REMOVED AND FOUND TO HAVE A FRACTURE BETWEEN THE 4 AND 5 CM LINE ON THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9411403 ↗
• InjuryNov 9, 2018Material Fragmentation; Physical Resistance/Sticking

  PER MS&S: NURSE ATTEMPTED TO REMOVE A PICC AND ABOUT 20CMS CAME OUT AND IT BECAME STUCK. THE PATIENT IS CHRONICALLY ILL AND HAS HAD 3 PICC LINES IN HIS RIGHT ARM. AN ULTRASOUND REVEALED A 2 CM CLOT/DVT IN THE BRACHIAL VEIN AROUND THE PICC. THE PICC IS DOCUMENTED AS BEING 41CMS IN LENGTH AND THERE IS 20CMS EXTERNAL. THEY WILL LEAVE THE PICC IN PLACE AND USE LOVENOX TO DISSOLVE THE CLOT AND REMOVE AT A LATER DATE. MS&S: EXPLAINED THAT THE PICC CAN GET STUCK IN AN STENOSIS OR ON A VALVE. DISCUSSED GROSHONG DESIGN. SUGGESTED THEY GET AND ARM ULTRASOUND OR X-RAY TO RULE OUT A KNOT IN THE CATHETER OR CLOT. DISCUSSED APPLYING HEAT AND OTHER MEASURES TO HELP THE VESSEL DILATE. ON (B)(6) 2018 LOVENOX WAS USED TO DISSOLVE THE CLOT WELL ENOUGH TO REMOVE THE LINE. PATIENT STILL REMAINS ON LOVENOX FOR FURTHER CLOT REMOVAL. CATHETER WAS DISCARDED AFTER REMOVAL, NO FURTHER PATIENT COMPLICATIONS AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; Thrombus

  MAUDE report 8055422 ↗