Stryker Neurovascular Recalls Expired Gateway PTA Balloon Catheters
Stryker Neurovascular is recalling Gateway PTA Balloon Catheters shipped to US customers beyond their expiration date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the use of an expired medical device, which is a low-risk contamination or labeling issue where no injuries have been reported, fitting the Moderate severity criteria.
Plain-English summary
Stryker Neurovascular is recalling specific units of the Gateway PTA Balloon Catheter. The recall is due to the fact that these units were shipped to US customers after they had passed their expiration date.
The affected product is the Gateway PTA Balloon Catheter, model M00320072209270, lot number 12693091, with an expiration date of June 2012. The device is indicated for balloon dilation of the stenotic portion of intracranial arteries to improve intracranial perfusion.
The recall covers one unit distributed to the states of Virginia, New Hampshire, Ohio, and Texas. The source text does not report any illnesses or injuries associated with the use of these expired devices.
The recalled product
- Product
- Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 1
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 (3)
- Model M00320072209270
- Lot number: 12693091
- Exp. Jun 2012.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Stryker Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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