Volcano TrakBack II Disposable Pullback Device — Class II medical device recall Z-2636-2014
Terminated recall by Volcano Corporation, reported 2014-09-24, distributed nationwide. Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the
| Recall number | Z-2636-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2014-08-13 |
| Classified | 2014-09-12 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, KR, MX, TH |
| Reason classes | sterility |
| Model numbers | 91003 |
Product
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
Reason for recall
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
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-2636-2014. 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.