ARROW IPN914732Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902157895), received between Nov 18, 2021 and Nov 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionNov 18, 2021Material Fragmentation; Material Fragmentation

  WHILE INSERTING THE CATHETER, THE TIP OF THE DILATOR BROKE IN THE PATIENT'S JUGULAR VEIN. THERE WAS NO CLINICAL CONSEQUENCE FOR THE PATIENT BECAUSE THE BROKEN TIP DID NOT ENTER THE BLOODSTREAM. THE PATIENT'S CONDITION IS REPORTED AS FINE. NO REPORT OF A REQUIRED MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12837907 ↗

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