RELAY PRO Thoracic Stent-Graft System — Class II medical device recall Z-1383-2024
Completed recall by Bolton Medical Inc., reported 2024-04-03, distributed nationwide. The stent-graft inside the delivery system was the incorrect size.
| Recall number | Z-1383-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bolton Medical Inc., Sunrise, FL, United States |
| Recall initiated | 2024-02-22 |
| Classified | 2024-03-27 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, DE, ES, FR, IT, JP, PL, TH |
| Quantity | 21 devices |
| UPC / GTIN / UDI-DI | 00843576100114, 00843576100183, 00843576100343, 00843576100572, 00843576100763, 00843576100824, 00843576100831, 00843576100954, 00843576101364, 00843576101449, 00843576101470, 00843576149632, 00843576149656, 00843576149847, 00843576150584, 00843576150607 |
| Lot numbers | 2112080111, 2112080147, 2112080148, 2112080158, 2112090117, 2112100328, 2112100333, 2112100383, 2112100385, B211130071, B211202319, B211203197, B211206395, B211207181, B211207227, B211208120, B211208162, B211209065, B211209068, B211209073, B211209120 |
| Model numbers | 28-CMP-3062-NC, 28-CMP-3074-MC, 28-M4-30-095-30U, 28-M4-32-155-32S, 28-M4-34-100-34U, 28-M4-36-250-32S, 28-M4-38-145-34S, 28-M4-38-190-38S, 28-M4-44-105-44S, 28-M4-46-155-46U, 28-N4-22-099-22S, 28-N4-22-159-22S, 28-N4-24-099-24S, 28-N4-28-204-24S, 28-N4-30-164-30U, 28-N4-32-164-28S, 28-N4-34-154-34U, 28-N4-34-209-30S, 28MC36A17536S2390, 28NC36N19038S2590 |
Product
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S; (f) Part number 28-M4-38-145-34S; (g) Part number 28-M4-38-190-38S; (h) Part number 28-M4-44-105-44S; (i) Part number 28-N4-22-099-22S; (j) Part number 28-N4-22-159-22S; (k) Part number 28-N4-24-099-24S; (l) Part number 28-N4-28-204-24S (m) Part number 28-N4-30-164-30U; (n) Part number 28-N4-32-164-28S; (o) Part number 28-N4-34-154-34U; (p) Part number 28-N4-34-209-30S; (q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and (r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC;
Reason for recall
The stent-graft inside the delivery system was the incorrect size.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1383-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.