The TREO ABDOMINAL STENT-GRAFT SYSTEM — Class II medical device recall Z-1689-2023
Ongoing recall by Bolton Medical Inc., reported 2023-06-14, distributed nationwide. Potential for the incorrect size stent-graft than the printed carton label.
| Recall number | Z-1689-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bolton Medical Inc., Sunrise, FL, United States |
| Recall initiated | 2023-05-03 |
| Classified | 2023-06-06 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, GB, IT |
| Quantity | 216 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00843576151963, 00843576151994, 00843576152007, 00843576152038, 00843576152076, 00843576152083, 00843576152090, 00843576152137, 00843576152144, 00843576152229, 00843576152342, 00843576152359, 00843576152366, 00843576152373, 00843576152441, 00843576152458, 00843576152472, 00843576152595, 00843576152601, 00843576152618, 00843576152656, 00843576152663, 00843576152670, 00843576152762, 08436045396747 and 23 more |
| Lot numbers | 2104120114, 2104170128, 2104170131, 2104170132, 2104170133, 2104230125, 2104230135, 2104230136, 2104230138, 2104230139, 2104230143, 2104230154, 2104230164, 2104230165, 2104230166, 2104230168, 2104230170, 2104230171, 2104230182, 2104230183, 2104230184, 2104230185, 2104230186, 2104230188, 2104230189, 2104230191, 2104230192, 2104230193, 2104230194, 2104230195, 2104230196, 2104230197, 2104230198, 2104230199, 2104230200, 2104230201, 2104230226, 2104230228, 2104230230, 2104230231 and 140 more |
| Model numbers | 2104170128, 2104170131, 2104170132, 2104170133, 2104230125, 2104230135, 2104230136, 2104230138, 2104230139, 2104230143, 2104230154, 2104230164, 2104230165, 2104230166, 2104230168, 2104230170, 2104230171, 2104230182, 2104230183, 2104230184, 2104230185, 2104230186, 2104230188, 2104230189, 2104230191 and 155 more |
Product
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanced under fluoroscopy to the location of the infrarenal aneurysm. The stent-graft is deployed at the intended location and creates a blood flow channel, excluding the aneurysm from blood pressure and flow.
Reason for recall
Potential for the incorrect size stent-graft than the printed carton label.
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-1689-2023. 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.