Collagen vascular grafts recalled over unapproved bovine raw material supplier

Plain-English summary

Artegraft Collagen Vascular Grafts, model numbers AG 616, AG 630, AG 636, AG 640, AG 645, AG 715, AG 730, AG 735, AG 740, AG 745, AG 750, AG 830, AG 840, AG 1015 and AG 1030, are being recalled.

The bovine carotid arteries used to produce the affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

The recall covers 28 units, distributed in California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Mississippi, North Carolina, North Dakota, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Washington. The FDA has classified the action as Class II.

The enforcement record describes a supplier approval gap rather than a defect found in the grafts themselves, and reports no injuries. Facilities holding affected model and lot numbers should follow LeMaitre's instructions.

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

• unapproved-supplier
• regulatory-noncompliance
• raw-material

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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