The Distal Access Catheter is a single-lumen — Class II medical device recall Z-1740-2024
Ongoing recall by Stryker Neurovascular, reported 2024-05-08, distributed nationwide. Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by r
| Recall number | Z-1740-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2024-04-03 |
| Classified | 2024-05-01 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 43 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 07613327313895 |
| Lot numbers | 0000486382 |
| Expiration dates | 2025-07-17 |
Product
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.
Reason for recall
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
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-1740-2024. 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.