ARROW IPN920043Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902192445), received between Jul 28, 2022 and Jul 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "SHEATH WAS INSERTED. ATTEMPT TO ADVANCE A JL 6 GUIDING CATHETER FAILED, STRONG RESISTANCE WAS FELT. SHEATH AND CATHETER WERE REMOVED AND A NEW SHEATH OF THE SAME LOT WAS INSERTED. THE SAME PROBLEM OCCURRED, AGAIN THE CATHETER COULD NOT BE ADVANCED. USER CHANGED TO A TERUMO SHEATH WHICH WAS SUCCESSFUL." NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. IT WAS REPORTED THE GUIDE CATHETERS THAT ARE INSERTED INTO THE SHEATH HAVE CURVED TIPS. WHEN INSERTING THE CATHETER THROUGH THE SHEATH, RESISTANCE IS FELT NEAR THE TIP OF THE SHEATH. THE SHEATH SEEMS TO TIGHTEN IN THE INNER LUMEN AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127105 ↗
• MalfunctionJul 28, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "SHEATH WAS INSERTED. ATTEMPT TO ADVANCE A JL 6 GUIDING CATHETER FAILED, STRONG RESISTANCE WAS FELT. SHEATH AND CATHETER WERE REMOVED AND A NEW SHEATH OF THE SAME LOT WAS INSERTED. THE SAME PROBLEM OCCURRED, AGAIN THE CATHETER COULD NOT BE ADVANCED. USER CHANGED TO A TERUMO SHEATH WHICH WAS SUCCESSFUL." NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. IT WAS REPORTED THE GUIDE CATHETERS THAT ARE INSERTED INTO THE SHEATH HAVE CURVED TIPS. WHEN INSERTING THE CATHETER THROUGH THE SHEATH, RESISTANCE IS FELT NEAR THE TIP OF THE SHEATH. THE SHEATH SEEMS TO TIGHTEN IN THE INNER LUMEN AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127102 ↗
• MalfunctionJul 28, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  CUSTOMER REPORTS "FOR TESTING PURPOSES IT WAS ATTEMPTED TO ADVANCE A JL 6 GUIDING CATHETER AND A JR 4 GUIDING CATHETER THROUGH THE SHEATH. THIS FAILED WITH BOTH CATHETERS, THE SHEATH WAS TIGHT." IT WAS REPORTED THE GUIDE CATHETERS THAT ARE INSERTED INTO THE SHEATH HAVE CURVED TIPS. WHEN INSERTING THE CATHETER THROUGH THE SHEATH, RESISTANCE IS FELT NEAR THE TIP OF THE SHEATH. THE SHEATH SEEMS TO TIGHTEN IN THE INNER LUMEN AT THE TIP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15125906 ↗