Recall record at a glance
| Official record | Z-1689-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Bolton Medical Inc. |
| Report date | Jun 14, 2023 |
| Recall initiation date | May 3, 2023 |
| Quantity | 216 units |
| Location | Sunrise, FL, United States |
Official product description
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.
Why the product was recalled
Potential for the incorrect size stent-graft than the printed carton label.
Distribution information
Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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