FDA Medical Device Recalls (openFDA)
Volcano Corporation: 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.
- Recall number
- Z-2636-2014
- Recalling firm
- Volcano Corporation
- 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.
- Status
- Terminated
- Initiated
- 2014-08-13
- Posted
- 2014-09-12
- Terminated
- 2015-06-30
- Reason
- Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
- Root cause
- Packaging
- Action
- Volcano sent an Urgent Product Recall Notification letter dated August 13, 2014, to all customers who received the device in the last 25 months. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product and return unused devices to the Volcano distribution center. Customers were asked to prepare the attached inventory log and then contact Volcano Customer Service at 800-228-4728, option 4 to arrange for return of any affected product in their inventory. A credit would be issued for any returned product. Customers with questions were asked to call 800-228-4728. For questions regarding this recall call 978-439-3586.
- Quantity
- 8251 total devices (3777 US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
- Lot, serial or model codes
- Part number 91003: All Lots
- 510(k) numbers
- ["K003938"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 2939520
- Firm city
- Rancho Cordova
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28