GORE ACUSEAL Vascular Graft Risk of Delamination and Reduced Blood Flow
W.L. Gore is recalling GORE ACUSEAL Vascular Grafts due to risk of delamination, which can reduce blood flow, cause cannulation difficulties, and lead to bleeding or bruising. Instructions for Use will be updated with enhanced warnings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm product (vascular graft with delamination risk). While delamination can cause serious complications—reduced blood flow, cannulation difficulties, bleeding, bruising, and need for reintervention—no hospitalizations or injuries are reported in the source text. The proactive instructions update places this at High rather than Severe.
Plain-English summary
W.L. Gore & Associates is recalling GORE ACUSEAL Vascular Grafts. Approximately 52,306 units with various reference numbers have been distributed.
The recalled grafts may experience delamination, a separation of the graft structure layers. This can reduce blood access flow, create cannulation difficulties during placement, and result in bleeding or bruising. Patients may require reintervention procedures to address these complications.
The affected units were distributed to medical facilities throughout the United States and internationally, including Canada, Germany, the United Kingdom, Italy, Spain, and other countries.
W.L. Gore is updating the Instructions for Use to further clarify techniques that may contribute to delamination risk and to add delamination to the device-related adverse events section. Healthcare providers should review the updated instructions and consult with the manufacturer regarding any affected units in their inventory.
The recalled product
- Product
- GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Vascular Graft
- Hazard
- delamination
- reduced-blood-flow
- bleeding
- bruising
- cannulation-difficulty
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- REF/UDI-DI: ECH050020J/04993024010758
- ECH050020W/00733132635450
- ECH050050J/04993024010772
- ECH050050W/00733132635474
- ECH060010A/00733132622573
- ECH060020A/00733132622597
- ECH060020J/04993024009967
- ECH060020W/00733132634729
- ECH060040/00733132605347
- ECH060040A/00733132605354
- ECH060040W/00733132619719
- ECH060050A/00733132626960
- ECH060050J/04993024009981
- ECH460045A/00733132634811
- ECH460045J/04993024010789
- ECH470045/00733132626977
Distribution
Distributed in 51 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WV
- WY
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