ARROW IPN032635Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902005240), received between Oct 19, 2023 and Oct 19, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K811627); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  CUSTOMER REPORTED "PATIENT COMPLAIN OF PAIN ON SITE WHEN CHECKED, THE TUBE SITE LEAKING AND PERITONEAL CATHETER WAS LEFT INSIDE PATIENT , RESULTING PATIENT FOR SURGERY ".

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 17965670 ↗
• InjuryOct 19, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  CUSTOMER REPORTED "PATIENT COMPLAIN OF PAIN ON SITE WHEN CHECKED, THE TUBE SITE LEAKING AND PERITONEAL CATHETER WAS LEFT INSIDE PATIENT , RESULTING PATIENT FOR SURGERY ".

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 17965601 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K811627. One submission often covers many models, so check the product and lot details in each record.

• Z-2380-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
• Z-1408-04 · Aug 2, 2004 · Terminated
  Peritoneal Lavage Kits, Model number AK-09000