COVERA AVFL08100Recalls & reported problems

Angiomed GmbH & Co. Medizintechnik KG · COVERA™ Vascular Covered Stent 8 mm x 100 mm (120 cm delivery catheter) (flared) · Class 3 · Implant

All models of COVERA (65)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741106996), received between Mar 27, 2025 and Mar 27, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Activation Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Activation Failure1
Material Deformation1

Patient problems

Insufficient Information1
Pain1
Swelling/ Edema1

Recent adverse event reports

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

InjuryMar 27, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure
IT WAS REPORTED THAT POST A STENT GRAFT PLACEMENT PROCEDURE AT THE CEPHALIC ARCH, THE STENT HAD ALLEGEDLY COLLAPSED AND FLOW WAS GOING AROUND IT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Insufficient Information; Pain; Swelling/ Edema
MAUDE report 21704674 ↗

Device details

UDI-DI	`00801741106996`
Brand	COVERA
Model	AVFL08100
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.

Other System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment devices

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COVERA AVSM08060
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COVERA AVSM09060
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COVERA AVSM10080
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COVERA AVSM10040
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1 recall15 reports
COVERA AVSM09080
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1 recall1 death14 reports
COVERA AVFM10060
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1 recall14 reports
COVERA AVSM10100
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All System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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