Volcano TrakBack II Disposable Pullback Device Recalled for Sterility Concerns
Volcano Corporation is recalling TrakBack II Disposable Pullback Devices because internal testing identified a potential breach to the sterile barrier that may impact product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility breach) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Volcano Corporation is recalling the TrakBack II Disposable Pullback Device, a sterile and nonpyrogenic single-use medical device used to move catheters steadily and precisely for uniform collection of imaging data. The recall involves 8,251 total devices, with 3,777 units distributed in the United States. The devices were distributed nationwide in the US and internationally to Korea, Thailand, Canada, Australia, Chile, and Mexico. The recall applies to Part number 91003, all lots.
The recall was initiated because internal testing identified a potential breach to the sterile barrier, which may impact the sterility of the product. The source text does not report any illnesses, injuries, or deaths associated with the use of these devices.
Healthcare facilities and consumers who have these devices should stop using them and contact Volcano Corporation for further instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Volcano Corporation
- Category
- Medical Device — Cardiac Imaging
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part number 91003: All Lots
Distribution
Distributed nationwide across the United States.
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