ARROW IPN000149Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902001979), received between Jun 15, 2023 and Aug 13, 2023 — classified as 3 malfunctions.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED WHEN THE IABP WAS PLACED ON 7/15, THE TELEFLEX SHEATH WAS LEAKING AFTER IT WAS INSERTED, AND A CRACK WAS NOTED AT THE HUB. THE PHYSICIAN HAD TO EXCHANGE THE SHEATH FOR A NEW ONE. THERE WAS NO PATIENT INJURY OR HARM. THE SHEATH WAS EXCHANGED WITHOUT ANY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538024 ↗
• MalfunctionAug 13, 2023Material Separation; Material Separation

  DURING AN IABP REMOVAL, THE SHEATH BROKE APART AS THE PHYSICIAN WAS REMOVING THE BALLOON CATHETER. NO FOREIGN BODIES WERE LEFT IN THE PATIENT. IT WAS REPORTED THE SHEATH BROKE AT THE HUB AND THE BROKEN PIECE REMAINED IN THE IABP CATHETER, NOTHING BROKE INSIDE THE PATIENT'S VESSEL. NO INTERVENTION WAS NEEDED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538017 ↗
• MalfunctionJun 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THE PHYSICIAN WAS REMOVING A 40CC BALLOON CATHETER FROM A BALLOON PUMP THROUGH THE 8F SHEATH AND THE SHEATH BROKE AT THE HUB/SHAFT OF THE SHEATH. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. ADDITIONALLY A MEDWATCH REPORT WAS RECEIVED AS FOLLOWS: "COULD NOT REPOSITION THE ITEM CORRECTLY AND THE BALLOON PUMP WAS REMOVED. MD PULLED BACK ON THE IABP TO REPOSITION AND WAS UNABLE TO GET IN CORRECT POSITION, MD REMOVED IABP AND WHEN REMOVING IABP THE 8F ARROWFLEX SHEATH COLLAPSED AND SNAPPED AT THE HUB. REINSTALLED THIS MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134927 ↗

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