CLASS II Device recall · Reported 24 Sep 2014 · FDA Enforcement Report

TrakBack II Disposable Pullback Device recalled by Volcano

Volcano is recalling Volcano TrakBack II Disposable Pullback Device, distributed nationwide in the US. The recall was initiated on 13 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number 91003: All Lots

Quantity recalled8251 total devices (3777 US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2636-2014
FDA event ID: 69049
Recalling firm: Volcano, Rancho Cordova, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Aug 2014
FDA classified: 12 Sep 2014
Reported: 24 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

13 Aug 2014	Recall initiated by company
12 Sep 2014	Classified by FDA	+30 days
24 Sep 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.

Nationwide

Questions about this recall

Is TrakBack II Disposable Pullback Device recalled?

Yes. Volcano recalled TrakBack II Disposable Pullback Device on 13 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-2636-2014.

Why was it recalled?

Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.

Which lots are affected?

Part number 91003: All Lots

Where was it sold?

Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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