ARROW IPN036836Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50801902120156), received between Aug 10, 2021 and Aug 10, 2021 — 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.

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-2382-2026 · 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.

• MalfunctionAug 10, 2021Material Separation; Material Separation

  COMPLAINT FOUND IN MAUDE DATABASE REPORTED AS:"PATIENT HAD A LEFT PERCUTANEOUS CHEST TUBE PLACED ON (B)(6) 2021 BY SELDINGER'S TECHNIQUE. IT HAS BEEN IN PLACE SINCE THAT TIME FUNCTIONAL. CXR ON (B)(6) 2021 NOTED A WORSENING PNEUMOTHORAX, BUT A WIRE DENSITY OBJECT WAS NOTED THAT DID NOT CORRELATE WITH A TELEMETRY WIRE. ULTIMATELY, THIS CHEST TUBE WAS EXCHANGED FOR A DIFFERENT TUBE, AND DURING THE EXCHANGE A PIECE OF THE GUIDEWIRE WAS IDENTIFIED AT THE END OF THE CATHETER WHILE IT WAS REMOVED. FDA SAFETY REPORT ID # (B)(4)."

  Patient problems: Insufficient Information

  MAUDE report 12300192 ↗