ARROW IPN000153Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902002013), received between Jun 14, 2023 and Jun 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K924607); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE DILATOR TIP WAS FOUND DAMAGED DURING USE ON THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132211 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924607. One submission often covers many models, so check the product and lot details in each record.

• Z-1064-2016 · Jan 12, 2016 · Terminated
  Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis
• Z-1491-2009 · Feb 11, 2009 · Terminated
  Arrow Super Arrow-Flex Percutaneous Sheath Introducers
• Z-0088-04 · Oct 22, 2003 · Terminated
  10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set