ARROW IPN039803Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902145809), received between Jan 14, 2022 and Jan 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2022Material Separation; Material Separation

  IT WAS REPORTED DURING INSERTION, THE SMARTSEAL INTRODUCER AND DILATOR BROKE ENTIRELY. BOTH PIECES WERE RETRIEVED FROM THE PATIENT WITH A SNARE. THE PATIENT WAS REPORTED TO BE FINE. NO INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258805 ↗
• MalfunctionJan 14, 2022Material Separation; Material Separation

  IT WAS REPORTED DURING INSERTION, THE SMARTSEAL INTRODUCER AND DILATOR BROKE ENTIRELY. BOTH PIECES WERE RETRIEVED FROM THE PATIENT WITH A SNARE. THE PATIENT WAS REPORTED TO BE FINE. NO INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258745 ↗

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