ARROW IPN032616Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902097965), received between Jan 15, 2026 and Jan 15, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K870572); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "8FR CATHETER WOULD KINK AT THE DISTAL 1CM AFTER REMOVAL OF THE 18GA NEEDLE. THE ISSUE OCCURRED WITH DIFFERENT KITS, SAME LOT NUMBER, ATTEMPTED BY 2 DIFFERENT PHYSICIANS ON THE SAME PATIENT WITH SAME RESULT. MULTIPLE THORACENTESIS ATTEMPTS WERE REQUIRED BUT THERE WERE NO SURGICAL OR LONG TERM INTERVENTIONS REQUIRED AS A RESULT." ASSOCIATED COMPLAINTS 9680794-2026-00031, 9680794-2026-00030 AND 9680794-2026-00029.

  Patient problems: Insufficient Information

  MAUDE report 24079512 ↗
• MalfunctionJan 15, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "8FR CATHETER WOULD KINK AT THE DISTAL 1CM AFTER REMOVAL OF THE 18GA NEEDLE. THE ISSUE OCCURRED WITH DIFFERENT KITS, SAME LOT NUMBER, ATTEMPTED BY 2 DIFFERENT PHYSICIANS ON THE SAME PATIENT WITH SAME RESULT. MULTIPLE THORACENTESIS ATTEMPTS WERE REQUIRED BUT THERE WERE NO SURGICAL OR LONG TERM INTERVENTIONS REQUIRED AS A RESULT." ASSOCIATED COMPLAINTS 9680794-2026-00031, 9680794-2026-00030 AND 9680794-2026-00029.

  Patient problems: Insufficient Information

  MAUDE report 24078755 ↗
• MalfunctionJan 15, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "8FR CATHETER WOULD KINK AT THE DISTAL 1CM AFTER REMOVAL OF THE 18GA NEEDLE. THE ISSUE OCCURRED WITH DIFFERENT KITS, SAME LOT NUMBER, ATTEMPTED BY 2 DIFFERENT PHYSICIANS ON THE SAME PATIENT WITH SAME RESULT. MULTIPLE THORACENTESIS ATTEMPTS WERE REQUIRED BUT THERE WERE NO SURGICAL OR LONG TERM INTERVENTIONS REQUIRED AS A RESULT." ASSOCIATED COMPLAINTS 9680794-2026-00031, 9680794-2026-00030 AND 9680794-2026-00029.

  Patient problems: Insufficient Information

  MAUDE report 24078316 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K870572. One submission often covers many models, so check the product and lot details in each record.

• Z-1966-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-01000-UPMS
• Z-1298-2018 · Oct 24, 2017 · Terminated
  ArrowClarke" PleuraSeal Thoracentesis Kit