ARROW IPN039726Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902145489), received between Apr 28, 2025 and Apr 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (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.

• MalfunctionApr 28, 2025Material Disintegration; Physical Resistance/Sticking; Material Disintegration; Physical Resistance/Sticking

  IT WAS REPORTED "DURING PLACEMENT OF AN ARTERIAL CATHETER TODAY AND WHEN THE PROVIDER INSERTED THE GUIDEWIRE, THE WIRE WOULD NOT RETRACT AND WHEN SHE PULLED THE ENTIRE WIRE AND NEEDLE OUT, THE WIRE APPEARED TO DISINTEGRATE AND COME APART. SHE NOTED NO ISSUES WITH THE WIRE OR POTENTIAL SHEARING DURING INSERTION." A NEW CATHETER WAS PLACED IN A DIFFERENT SITE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICALLY ILL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920153 ↗

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