ARROW IPN038428 (REF SAC-00522-1A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902140606), received between Mar 12, 2025 and Mar 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2391-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Material Separation; Material Separation

  IT WAS REPORTED "PHYSICIAN WAS ADVANCING THE CATHETER OVER THE GUIDEWIRE AND NOTICED THAT IT FELT DIFFERENT. DISCOVERED THAT THE CATHETER HAD BROKEN NEAR THE HUB.". A NEW CATHETER WAS PLACED USING A MICROINTRODUCER TO COMPLETE THE PROCEDURE. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584475 ↗

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