ARROW IPN037650Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801902129915), received between Mar 11, 2025 and May 12, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K171146); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Device Damaged Prior to Use; Material Twisted/Bent

  IT WAS REPORTED THAT UPON OPENING THE DEVICE PACKAGING, A GUIDEWIRE WAS OBSERVED TO BE FRACTURED (KINKED). THE ISSUE WAS IDENTIFIED PRIOR TO USE, AND THE DEVICE WAS NOT INTRODUCED TO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT INJURY OR ADVERSE HEALTH CONSEQUENCES WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148778 ↗
• MalfunctionMar 11, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "WHEN PERFORMING THE CATHETERIZATION, THE BENT GUIDE IS OBSERVED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574792 ↗
• MalfunctionFeb 11, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "ON 19 JANUARY 2026, IN THE OPERATING THEATRE, WE HAD AN ISSUE WITH A SAC-00822-PBX ARTERIAL CATHETER. THE INTRODUCER GUIDE BENT, REQUIRING THE USE OF ANOTHER ONE." A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313931 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "FOLDED GUIDE". THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632328 ↗
• MalfunctionAug 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "PATIENT WITH INDICATION FOR ARTERIAL CATHETER PLACEMENT; DURING THE PURGING OF THE DEVICE, THE WHITE PROTECTOR IS REMOVED AND A FRACTURED GUIDE IS OBSERVED IN THE BODY OF THE CATHETER." THIS WAS FOUND PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770508 ↗
• MalfunctionJun 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "GUIDE FOLDED IN THE PACKAGING". THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205144 ↗
• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN OPENING THE ARTERIAL LINE CATHETER, THE GUIDEWIRE WAS FOUND TO BE BENT. THE DEVICE WAS REPLACED. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719247 ↗
• MalfunctionMar 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING THE INTRODUCTION OF THE SELDINGER GUIDE, USING THE NEEDLE SUPPLIED IN THE KIT, INITIAL RESISTANCE WAS PERCEIVED. THE GUIDE WAS THEN RETRACTED, WHICH, AS CAN BE SEEN, WAS DEFORMED." COMPRESSION WAS APPLIED TO THE PUNCTURE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650524 ↗
• MalfunctionMar 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT UPON OPENING THE ARTERIAL KIT, EVIDENCE OF A BENT GUIDEWIRE WAS OBSERVED. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575290 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171146. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE