Z-2636-2014Class II

Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to...

Name: Z-2636-2014 Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to...
Creator: Volcano Corporation
Published: 2014-08-13
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2014-08-13 / Terminated / root cause: packaging

FDA source

Volcano Corporation began a recall of Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing... on 2014-08-13. FDA classified it as Class II and gives the reason as "Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2636-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-13
Posted: 2014-09-12
Terminated: 2015-06-30
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.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Root cause tag: packaging
FDA 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 in commerce: 8251 total devices (3777 US)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
Product codes and lots: Part number 91003: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2636-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2636-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12

Product code DQO

K003938Class IITrak Back IIJomed, Inc. / cleared 2001-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)