ARROW IPN035671Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902090201), received between Dec 13, 2023 and Dec 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: THE CATHETER WAS REMOVED DUE TO MALFUNCTION. ONCE REMOVED THE CATHETER SEEMED TO HAVE LEAKING AROUND THE LUMENS WHERE IT MEETS THE BODY OF THE CATH. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318828 ↗
• MalfunctionDec 13, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: THE CATHETER IS PULLING AIR BUBBLES NEAR THE ARTERIAL PORTION OF THE CATHETER WHERE THE LUMENS MEET THE CUFF. PRODUCT IS STILL IN PATIENT.THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT.THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318661 ↗

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