Per-Q-Cath CK000244Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741043659), received between Nov 30, 2018 and Dec 7, 2018 — classified as 2 malfunctions.

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

• MalfunctionDec 7, 2018Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE PICCS IN THE PAST, AND COULD NOT HAVE A PICC PLACED ON THE LEFT SIDE (DIFFICULT PATIENT ANATOMY). THE PLACER HAD A DIFFICULT TIME PLACING IN THE RIGHT SIDE. IT WAS STATED THE WIRE WAS BENT WHEN IT WAS REMOVED. (B)(6) 2018 - RETURNED WIRE IS KINKED. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH STATED, "UPON COMPLETION OF PICC INSERTION, THE STYLET WAS OBSERVED TO HAVE A FRACTURE AT THE TIP AT 2CM MARK."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142211 ↗
• MalfunctionNov 30, 2018Fracture; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS A FRACTURED GUIDEWIRE. IT WAS STATED THE WIRE WAS BENT WHEN IT WAS TAKEN OUT OF THE PATIENT. THE WIRE TIP BROKE OFF IN THE BAG ONCE IT WAS SET ASIDE FOR INVESTIGATION. PATIENT ANATOMY WAS NOT DIFFICULT. ADDITIONAL INFORMATION REC'D VIA MEDWATCH STATED, "SINGLE LUMEN PICC TRIMMED TO 37 CM. INTRODUCED TO ABOUT 15 CM, THEN NOTED RESISTANCE AND PICC REMOVED. WHEN INSPECTING THE STYLET, IT WAS FRACTURED AT 2 CM FROM THE TIP."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8121590 ↗