Artegraft Collagen Vascular Grafts Recalled Due to Unapproved Material Supplier
LeMaitre Vascular is recalling 28 units of Artegraft Collagen Vascular Grafts across 15 model numbers because raw bovine carotid arteries were sourced from a supplier not reviewed or approved by FDA.
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 high-risk surgical device (vascular grafts used in vascular procedures). The hazard is the use of raw materials from an unapproved supplier, which creates potential quality and safety risks. Although no injuries or adverse events are reported, this qualifies as a risk-of-harm product where regulatory non-compliance and the critical-use nature of the device warrant a High severity rating.
Plain-English summary
LeMaitre Vascular is recalling Artegraft Collagen Vascular Grafts due to regulatory non-compliance in the sourcing of raw materials. The recall affects 28 units across 15 model numbers. The bovine carotid arteries used to manufacture the affected grafts were sourced from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
The affected grafts were distributed nationwide to healthcare facilities in 17 states: California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Mississippi, North Carolina, North Dakota, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, and Washington.
Vascular grafts are surgical implants used to restore blood flow in vascular procedures. The use of materials from unapproved suppliers in such critical-use devices represents a quality and safety risk that prompted this recall.
The recalled product
- Product
- Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular Graft
- Hazard
- unverified-supplier
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 (20)
- Model Numbers: (1) AG 616
- (2) AG 630
- (3) AG 636
- (4) AG 640
- (5) AG 645
- (6) AG 715
- (7) AG 730
- (8) AG 735
- (9) AG 740
- (10) AG 745
- (11) AG 750
- (12) AG 830
- (13) AG 840
- (14) AG 1015
- (15) AG 1030
- UDI-DIs: (1) 00316837000213
- (2) 00316837000220
- (3) 00316837000237
- (4) 00316837000244
- (5) 00316837000251
Distribution
Distributed nationwide across the United States.
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