ACCESSRAIL Platform — Class II medical device recall Z-2271-2023
Ongoing recall by Maquet Cardiovascular, LLC, reported 2023-08-09, distributed nationwide. The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabil
| Recall number | Z-2271-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2023-06-28 |
| Classified | 2023-07-31 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BD, BR, CL, CO, IR, JO, MX, MY, NL, SG, TH, TW |
| Quantity | 785 units |
| UPC / GTIN / UDI-DI | 00607567700215 |
| Model numbers | C-DB-1000, SB-1000 |
Product
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
Reason for recall
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
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-2271-2023. 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.