Quick Facts at a Glance
- Recall Date
- August 26, 2025
- Hazard Level
- HIGH
- Brand
- Gore
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Gore
- Product type
- GORE ACUSEAL Vascular Graft
- Model numbers
- ECH050020J/04993024010758, ECH050020W/00733132635450, ECH050050J/04993024010772, ECH050050W/00733132635474, ECH060010A/00733132622573, ECH060020A/00733132622597, ECH060020J/04993024009967, ECH060020W/00733132634729 +9 more
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 26, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact W L Gore & Associates, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Gore ACUSEAL Vascular Grafts are used in vascular access procedures to create or repair grafts in patients. The devices are designed for durable vascular repair and access.
Why This Is Dangerous
Delamination can compromise graft integrity, reducing flow and complicating cannulation. This increases the risk of bleeding and may require additional procedures.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Affected patients may require monitoring, additional interventions, and coordination with healthcare teams. Hospitals should review devices on hand and ensure staff follow the updated warnings.
Practical Guidance
How to identify if yours is affected
- Review model numbers and serial numbers against the recall list
- Inspect device labeling and IFU for the MD183888 Revision 4 guidance
- Cross-check inventory with Gore recall notices
Where to find product info
Identification details appear on device labels and accompanying IFU MD183888 Revision 4; recall notices provide serial ranges
What timeline to expect
Recall processing and replacement guidance may take weeks to months and will be coordinated through healthcare providers
If the manufacturer is unresponsive
- Escalate to the hospital’s vascular surgery leadership
- Document communications with Gore and the facility’s recall coordinator
- File a formal inquiry with Gore through official channels
How to prevent similar issues
- Verify device compatibility and delamination risk with surgeons
- Maintain updated IFUs and staff training on device handling
- Monitor for updates from Gore and FDA recall notices
Documentation advice
Keep the recall letter, device labels, model and serial numbers, purchase records, and all correspondence with Gore or healthcare providers.
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Product Details
Model numbers: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A. Serial-number range: 6597081PP001 to 9853822PP024. Instructions for Use: MD183888 Revision 4. Quantity recalled: 52,306. Recall date: 2025-08-26. Status: Active. Distribution: United States and international markets.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Qty recalled: 52,306 units
- Model numbers: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, E
- Serial-number range: 6597081PP001–9853822PP024
- Instructions for Use MD183888 Revision 4
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Safety Guide
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