Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide 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 does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of the Guider Softip XF guide catheter, specifically the GUIDER/MP XF/8FR/100 cm model (Model number M003101480). The recall covers specific lots with expiration dates of 11/30/18 and 01/31/19. 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 such as Argentina, Australia, Canada, France, Germany, Japan, and the United Kingdom.
Healthcare providers and consumers should stop using the affected devices and contact Stryker Neurovascular for further instructions on how to return or replace the products.
The recalled product
- Product
- Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. 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 (2)
- Lot 18713574. Expiration 11/30/18. Lot s18849984
- 18848795. Expiration 01/31/19.
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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