Stryker Recalls Guider Softip XF Guide Catheters for Hub Leaks
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. The source text describes a potential defect (hub leaks) without reporting any specific injuries, illnesses, or deaths, which aligns with the criteria for a moderate severity score.
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of the Guider Softip XF Guide Catheter, Model number H965100470. The recall covers specific lots with expiration dates in December 2018 and January 2019. These medical devices are intended to facilitate the placement of interventional devices into the neurovascular system.
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 internationally to numerous countries.
Healthcare providers and facilities should stop using the affected devices and contact Stryker Neurovascular for further instructions on the recall process.
The recalled product
- Product
- Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
- Manufacturer
- Stryker Neurovascular
- Hazard
- 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)
- Lots 18713978
- 18714267
- 18716054. Expiration 12/31/2018. Lots 18786405
- 18786441
- Expiration date -1/31/2019
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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