ASEPT 622284Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964317330), received between Jul 22, 2020 and Jul 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K093796, K221779); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  PHYSICIAN WAS TWISTING THE CATHETER TOGETHER DURING A PROCEDURE AND NOTED THAT IT WAS LEAKING AND WAS CRACKED. ANOTHER ASEPT CATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311212 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093796, K221779. One submission often covers many models, so check the product and lot details in each record.

• Z-0568-2015 · Oct 20, 2014 · Terminated
  ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.