PowerPICC SOLO CK000663ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741134821), received between Apr 12, 2018 and Apr 13, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Kinked” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2018Kinked

  IT WAS REPORTED THAT THE GUIDEWIRE KINKED DURING INSERTION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7428770 ↗
• MalfunctionApr 12, 2018Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT CAME TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF CHEST PAIN AND COUGH. IT WAS DISCOVERED DURING THE DIAGNOSTIC WORKUP THAT THE PATIENT HAD A LINEAR THIN METALLIC FOREIGN BODY IN THE LEFT HILUM. THE PATIENT HAD A PULMONARY ARTERY ANGIOGRAM WITH WIRE FRAGMENT RETRIEVAL ON (B)(6) 2018. IT IS ASSUMED THAT THE EVENT ALLEGEDLY OCCURRED DURING PLACEMENT ON (B)(6) 2018 AND DISCOVERED (B)(6) 2018 WHEN THAT PATIENT WENT TO THE HOSPITAL. IT WAS ALSO NOTED THAT THE FRAGMENT FURTHER BROKE INTO TWO PIECES AFTER RETRIEVAL BY RADIOLOGY DEPARTMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7425265 ↗