ARROW IPN035653Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902090027), received between Oct 27, 2025 and Oct 27, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

1 other recall cover devices cleared under the same FDA submission (K141051); 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.

• MalfunctionOct 27, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "UPON CHECKING BY THE RENAL CARE NURSE, IT WAS EVALUATED THE PERMCATH PATENCY, IT WAS NOTED TO BE OBSTRUCTED". THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS. THE PATIENT'S CURRENT CONDITION IS REPROTED AS "CRITICAL".

  Patient problems: Insufficient Information

  MAUDE report 23391646 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141051. One submission often covers many models, so check the product and lot details in each record.

• Z-2157-2026 · Apr 10, 2026 · Open, Classified
  Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272