ARROW IPN921154Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902200850), received between Jun 8, 2026 and Jun 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Material Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATING PHYSICIAN OBSERVED THAT THE RUBBER PACKING COMPONENT SEPARATED AND FELL OUT OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND REPLACEMENT WITH ANOTHER DEVICE. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE. A TOTAL OF THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477453 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATING PHYSICIAN OBSERVED THAT THE SHEATH CONNECTION COMPONENT DETACHED FROM THE DEVICE. THE AFFECTED DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE, ALLOWING THE PROCEDURE TO CONTINUE WITHOUT FURTHER COMPLICATION. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND THAT DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447956 ↗
• MalfunctionJun 8, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATING PHYSICIAN HAD DIFFICULTY WITH ADVANCEMENT OF THE SUPER ARROW FLEX (SAF) SHEATH AND DILATOR. THE PHYSICIAN OBSERVED THAT THE TIP WAS DENTED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND REPLACEMENT WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435428 ↗
• MalfunctionJun 8, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATING PHYSICIAN HAD DIFFICULTY WITH ADVANCEMENT OF THE SUPER ARROW FLEX (SAF) SHEATH AND DILATOR. THE PHYSICIAN OBSERVED THAT THE TIP WAS DENTED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND REPLACEMENT WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435201 ↗