ARROW IPN920537Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902193916), received between Jun 1, 2022 and Feb 15, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED "PATIENT LOST CONSCIOUSNESS DUE TO A CLOT STROKE LAST NIGHT". NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Stroke/CVA

  MAUDE report 16382010 ↗
• InjuryJun 1, 2022Material Separation; Material Separation

  PATIENT WAS BROUGHT TO INTERVENTIONAL RADIOLOGY (IR) FOR FISTULOGRAM WITH POSSIBLE INTERVENTION. HOWEVER, THERE WAS AN ISSUE WITH THE ARTERIAL LINE BEFORE THE PATIENT WENT DOWN AND THE RADIAL ARTERIAL LINE WAS RETAINED IN THE PATIENT AFTER REMOVAL. THE FISTULOGRAM WAS PUT ON HOLD UNTIL THE ARTERIAL LINE ISSUE WAS RESOLVED. A RADIAL ARTERY THROMBECTOMY WAS PERFORMED AND THE CATHETER WAS REMOVED FULLY INTACT WITH BRISK BLEEDING POST THROMBECTOMY. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14569499 ↗