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COVERA AVSL09040Recalls & reported problems

Angiomed GmbH & Co. Medizintechnik KG · COVERA™ Vascular Covered Stent 9 mm x 40 mm (120 cm delivery catheter) (straight) · Class 3 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741106781), received between Mar 19, 2020 and Mar 19, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (2 reports).

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

Device problems

  • Obstruction of Flow2

Patient problems

  • Stenosis2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Pain1

Recent adverse event reports

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

  • InjuryMar 19, 2020Obstruction of Flow; Obstruction of Flow

    IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY NINE MONTHS POST INDEX PROCEDURE, 60% STENOSIS WAS IDENTIFIED IN THE TARGET LESION. IT WAS FURTHER REPORTED THAT STANDARD PTA WAS SUCCESSFULLY PERFORMED FOR RE-INTERVENTION DUE TO THE DYSFUNCTION IN PULSATILITY. THE CURRENT PATIENT STATUS IS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Stenosis

    MAUDE report 9856134 ↗
  • InjuryMar 19, 2020Obstruction of Flow; Obstruction of Flow

    IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY 1-YEAR POST INDEX PROCEDURE, 70% TARGET LESION STENOSIS AND STANDARD PTA WAS PERFORMED TO TREAT LESION. IT WAS FURTHER REPORTED APPROXIMATELY 1 YEAR 11-MONTH POST INDEX PROCEDURE 50% STENOSIS WAS IDENTIFIED AND STANDARD PTA WAS PERFORMED TO TREAT LESION. THE CURRENT PATIENT STATUS IS UNKNOWN.

    Patient problems: Stenosis

    MAUDE report 9856101 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.