Cytal® WSM0710 (UDI 00386190001035)Recalls & reported problems
Acell, Inc. · Cytal® Wound Matrix 2-Layer 7 X 10 cm · Class U
All models of Cytal (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386190001035), received between Sep 5, 2025 and Sep 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
A FACILITY REPORTED CYTAL WOUND MATRIX (ID (B)(6)) SHEETS ARE STILL VERY VISIBLE IN THE WOUND AND NOT INTEGRATED OR GENERATING TISSUE, EVEN AFTER A FULL WEEK WITH VAC. NO INFORMATION WAS PROVIDED IN REGARDS PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 22977402 ↗
Other DRESSING, WOUND, COLLAGEN devices
- PriMatrix® 607-001-812Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® WSM0505Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-880Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-440Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-125Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- Karl Schumacher TAPE RCWT0001Karl Schumacher Dental Instrument CO., Inc. · Dressing, Wound, Collagen1 recall0 reports
- DermaCol 100 00300ESion Brands LLC · Dressing, Wound, Collagen1 recall0 reports
- DermaCol 100 00300ESion Brands LLC · Dressing, Wound, Collagen1 recall0 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
- 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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