Stryker Neurovascular Recalls Guider Softip XF Guide Catheters
Stryker Neurovascular is recalling 1,478 Guider Softip XF Guide Catheters due to a manufacturing defect that could cause hub leaks.
What this means for you
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, and the source text describes a potential defect (hub leaks) without reporting any specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of the Guider Softip XF Guide Catheter, specifically the GUIDER/40DEG XF/6FR/90CM model (Model number: H965100420). These medical devices are intended to facilitate the placement of interventional devices into the neurovascular system. The recall covers specific lots with expiration dates ranging from December 31, 2018, to March 31, 2019.
The recall was initiated because the firm became aware of a manufacturing non-conformance that could lead to hub leaks in the resulting product. The affected devices were distributed worldwide, including in the United States (Alaska, Illinois, and Ohio) and in numerous international markets such as Canada, the United Kingdom, and Germany.
Healthcare providers and facilities should stop using the affected devices and contact Stryker Neurovascular for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
- Manufacturer
- Stryker Neurovascular
- Affected units
- 1,478
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 (5)
- Lot s: 18725976
- 18726252
- 18726453. Expiration 12/31/18. Lot: 18771999
- Expiration 01/31/2019. Lot 19022528
- Expiration 03/31/2019.
Distribution
Part of a larger recall action
This product is one of 15 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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