FDA Device recall Z-2636-2014
Volcano TrakBack II Disposable Pullback Device
- FDA Device
- Class II
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class II recall of Volcano TrakBack II Disposable Pullback Device by Volcano, citing internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2636-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-13 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Volcano |
| Distribution | US |
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
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Identifiers
| code_info | Part number 91003: All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Volcano
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
FDA Device · Class II · 2026-10-07 · Volcano - Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
FDA Device · Class II · 2025-08-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Device · Class II · 2022-06-22 · Volcano
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2636-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.