Epicel (cultured epidermal autografts) N/ARecalls & reported problems
Vericel Corporation · Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns. · Class f · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 3
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI W41020AU201S1969), received between Aug 13, 2024 and Nov 7, 2025 — classified as 3 deaths, 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Product Quality Problem2
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Atrial Fibrillation1
- Coagulation Disorder1
- Disseminated Intravascular Coagulation (DIC)1
- Hemorrhage/Blood Loss/Bleeding1
- Sepsis1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2025Product Quality Problem; Product Quality Problem
12 GRAFTS WERE RUNNY AND UNUSABLE DUE TO THE CELLS SLIDING OFF THE BACKING WITH THE CONSISTENCY OF SNOT [PRODUCT QUALITY ISSUE].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23494538 ↗DeathApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ISCHEMIC BOWEL DISEASE [INTESTINAL ISCHAEMIA].
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21738872 ↗DeathJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PULMONARY HEMORRHAGE [PULMONARY HAEMORRHAGE] MEDICATION REFRACTORY ATRIAL FIBRILLATION [ATRIAL FIBRILLATION] TRANSFUSION-ASSOCIATED RELATED THROMBOCYTOPENIA [THROMBOCYTOPENIA] SEPSIS [SEPSIS].
Patient problems: Atrial Fibrillation; Coagulation Disorder; Hemorrhage/Blood Loss/Bleeding; Sepsis
MAUDE report 21147255 ↗DeathNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISSEMINATED INTRAVASCULAR COAGULATION (DIC) [DISSEMINATED INTRAVASCULAR COAGULATION].
Patient problems: Disseminated Intravascular Coagulation (DIC)
MAUDE report 20794715 ↗MalfunctionAug 13, 2024Leak/Splash; Product Quality Problem; Leak/Splash; Product Quality Problem
LOOSE PINK LIQUID WAS NOTED ON THE OUTSIDE OF THE CARTRIDGES IN ONE SLEEVE OF TRAYS [PRODUCT LEAKAGE].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19971238 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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