ARROW IPN920702Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902196955), received between Jul 30, 2026 and Aug 24, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Device Damaged Prior to Use; Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50421970 ↗
• MalfunctionAug 24, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421888 ↗
• MalfunctionJul 30, 2026Device Damaged Prior to Use; Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50093732 ↗
• MalfunctionJul 30, 2026Device Damaged Prior to Use; Material Twisted/Bent

  It was reported that, upon opening a sterile arterial catheter kit, the anesthesiologist and nursing staff observed that the spring wire guide (SWG) was kinked and bent. A second kit was opened and used to complete the procedure. The issue was identified prior to patient use, and the affected device was not used. There was no patient involvement and no patient injury, adverse health consequences, or clinically significant harm associated with this event. No additional medical intervention was required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090269 ↗

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