COVERA AVSL07100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741106712), received between Jul 13, 2021 and Jul 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Retraction Problem” (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. Dec 22, 2022Open, Classified

   An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

   Z-1108-2023 · Root cause: Unknown/Undetermined by firm · 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.

• MalfunctionJul 13, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY HAD DIFFICULT TO RETRACT THROUGH SHEATH. IT WAS FURTHER REPORTED THAT CATHETER REMOVED SHEATH AND CATHETER OVER THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12156356 ↗