CLASS II ONGOING Device recall · Reported 15 Oct 2025 · FDA Enforcement Report
Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular
LeMaitre Vascular is recalling Artegraft Collagen Vascular Graft. The recall was initiated on 25 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0072-2026
- FDA event ID
- 97567
- Recalling firm
- LeMaitre Vascular, North Brunswick, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Aug 2025
- FDA classified
- 8 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 25 Aug 2025 | Recall initiated by company | |
| 8 Oct 2025 | Classified by FDA | +44 days |
| 15 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Product as listed by the FDA
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
Where it was distributed
No US distribution. International distribution to Great Britian and Switzerland.
Questions about this recall
Why was it recalled?
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Which lots are affected?
Model/Catalog/Part Number, UDI-DI (lot Numbers): 1. AG630M, 00316837000015 (24H361-021, 24H361-022, 24HH359-016). 2. AG636M, 00316837000022 (24H380-009). 3. AG730M, 00316837000060 (24H380-014, 24H380-004). 4. AG740M, 00316837000084 (24H380-003, 24H380-002). 5. AG845M, 00316837000138 (24HH350-017, 24HH359-011). Expiration date: 28 Jul 2027.
Where was it sold?
No US distribution. International distribution to Great Britian and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LeMaitre Vascular
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Artegraft Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | Nationwide |
| Device | CLASS II | Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | AR |
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