Reported Apr 3, 2024 · Completed
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card,…
Bolton Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bolton Medical Inc. · 799 International Pkwy · Sunrise, FL · 33325-6220
Is this the product you have?
18 of 18 products
| Model / number | Barcodes | Product as published |
|---|---|---|
28-M4-34-100-34U | 843576149656 | (a) - Lot #2112080111 and #2112080158, UDI 843576149656 |
28-M4-30-095-30U | 843576149632 | (b) - Lot #2112080147 and #2112080148, UDI 843576149632 |
28-M4-46-155-46U | 843576149847 | (c) - Lot #2112100328, UDI 843576149847 |
28-M4-32-155-32S | 843576100183 | (d) - Lot #B211209120, UDI 843576100183 |
28-M4-36-250-32S | 843576100763 | (e) - Lot #B211203197, UDI 843576100763 |
28-M4-38-145-34S | 843576100572 | (f) - Lot #B211206395, UDI 843576100572 |
28-M4-38-190-38S | 843576100343 | (g) - Lot #B211202319, UDI 843576100343 |
28-M4-44-105-44S | 843576100114 | (h) - Lot #B211209068, UDI 843576100114 |
28-N4-22-099-22S | 843576100824 | (i) - Lot #B211208120, UDI 843576100824 |
28-N4-22-159-22S | 843576100954 | (j) - Lot #B211208162, UDI 843576100954 |
28-N4-24-099-24S | 843576100831 | (k) - Lot #B211130071 and #B211207227, UDI 843576100831 |
28-N4-28-204-24S | 843576101449 | (l) - Lot #B211209065, UDI 843576101449 |
28-N4-30-164-30U | 843576150584 | (m) - Lot #2112100333, UDI 843576150584 |
28-N4-32-164-28S | 843576101364 | (n) - Lot #B211207181, UDI 843576101364 |
28-N4-34-154-34U | 843576150607 | (o) - Lot #2112090117, UDI 843576150607 |
28-N4-34-209-30S | 843576101470 | (p) - Lot #B211209073, UDI 843576101470 |
28-CMP-3062-NC | (q) - Lot #2112100385, no UDI | |
28-CMP-3074-MC | and (r) - Lot #2112100383, no UDI |
- Amount recalled
- 21 devices
Where it was sold
Why it was recalled
The stent-graft inside the delivery system was the incorrect size.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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