CardioCel Cardiovascular Patch UC0404Recalls & reported problems
Admedus Regen Pty Ltd · CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture · Class 2 · Implant
- 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 09348992000594), received between Sep 26, 2024 and Sep 26, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Stenosis” (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
Most reported problems
Device problems
- Device Stenosis1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2024Device Stenosis; Device Stenosis
ANTERIS RECEIVED A REPORT FROM TEH DISTRIBUTOR THAT A PHYSICIAN REPORTED THAT THE CARDIOCEL PATCH HAD THICKENED (DESCRIBED AS "PEEL) AFTER A VESSEL RECONSTRUCTION RESULTING IN THICKENING AND NARROWING OF THE VESSEL REPAIR.
Patient problems: Stenosis
MAUDE report 20312785 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.