COVERA AVFM07040Recalls & reported problems

Angiomed GmbH & Co. Medizintechnik KG · COVERA™ Vascular Covered Stent 7 mm x 40 mm (80 cm delivery catheter) (flared) · Class 3 · Implant

All models of COVERA (65)

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

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741106460), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 malfunction.

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. 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.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

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.

MalfunctionApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST STENT GRAFT PLACEMENT, THE PATIENT HAD ALLEGEDLY EXPERIENCED SWELLING FROM UPPER ARM TO THE ELBOW AREA. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749651 ↗

Device details

UDI-DI	`00801741106460`
Brand	COVERA
Model	AVFM07040
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

COVERA AVSM10060
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall33 reports
COVERA AVSM08060
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall21 reports
COVERA AVSM09060
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall18 reports
COVERA AVSM10080
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall16 reports
COVERA AVSM10040
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall15 reports
COVERA AVSM09080
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall1 death14 reports
COVERA AVFM10060
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall14 reports
COVERA AVSM10100
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall13 reports

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 · each recall links to the FDA recall notice
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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