ARROW IPN000125Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902001702), received between Jun 19, 2021 and Jun 19, 2021 — classified as 1 malfunction.

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

• MalfunctionJun 19, 2021Material Separation; Material Separation

  IT WAS REPORTED WHEN WITHDRAWING THE DILATOR THE HUB SNAPPED OFF LEAVING THE DILATOR FREE IN THE SHEATH. THE USER MANAGED TO OPEN THE END OF THE SHEATH UP, ADVANCE FURTHER AND GRAB THE BROKEN DILATOR WITH FORCEPS. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029958 ↗

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