Class II — Bolton Medical Inc.
| Recalling firm | BOLTON MEDICAL, INC. |
|---|---|
| Registered facility | BOLTON MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | The stent-graft inside the delivery system was the incorrect size. |
| 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 numbe… |
| Quantity | 21 devices |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The countries of Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand. |
| Initiated | 2024-02-22 |
| Classified | 2024-03-27 |
| Recall number | Z-1383-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bolton Medical Inc. (Z-1383-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93873/
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