COVERA AVSL10060Recalls & reported problems

Angiomed GmbH & Co. Medizintechnik KG · COVERA™ Vascular Covered Stent 10 mm x 60 mm (120 cm delivery catheter) (straight) · Class 3 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741106842), received between Jul 19, 2024 and Jul 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1
Detachment of Device or Device Component1
Misfire1
Positioning Failure1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 19, 2024Break; Positioning Failure; Misfire; Detachment of Device or Device Component; Break; Positioning Failure; Misfire; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE WHEEL OF THE DEVICE WAS ALLEGEDLY BROKE AND DETACHED. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19781418 ↗

Device details

UDI-DI	`00801741106842`
Brand	COVERA
Model	AVSL10060
Company	Angiomed GmbH & Co. Medizintechnik KG
Product code	PFV · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Nov 25, 2024

Device type (GMDN): Central/peripheral venous endovascular stent-graft

A non-bioabsorbable tubular device designed to be implanted in a central and/or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis; it is not intended for coronary or intracranial venous stenting. It is a mesh structure made of metal [e.g., nickel-titanium alloy] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ and disposable devices associated with implantation may be included.

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