COVERA AVFM06100Recalls & reported problems
Angiomed GmbH & Co. Medizintechnik KG · COVERA™ Vascular Covered Stent 6 mm x 100 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 00801741106453), received between Apr 6, 2022 and Apr 6, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
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
- Break1
- Malposition of Device1
- Misfire1
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 6, 2022Break; Misfire; Malposition of Device; Break; Misfire; Malposition of Device
IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14020253 ↗
Other System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment devices
- COVERA AVSM10060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall33 reports
- COVERA AVSM08060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall21 reports
- COVERA AVSM09060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall18 reports
- COVERA AVSM10080Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall16 reports
- COVERA AVSM10040Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall15 reports
- COVERA AVSM09080Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall1 death14 reports
- COVERA AVFM10060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall14 reports
- COVERA AVSM10100Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall13 reports
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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