Stryker Recalls Guider Guide Catheters Due to Manufacturing Defect
Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing non-conformance that could lead to hub leaks.
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 medical device with a potential defect (hub leaks) that poses a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of the Guider Softip XF and GUIDER MPXF 5F 90CM guide catheters, model number M003100630. The recall covers lots 18845284 and 18845814, which have an expiration date of January 31, 2019.
The firm initiated the recall after becoming aware of a manufacturing non-conformance that could result in hub leaks in the affected devices. These catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
The affected devices were distributed worldwide, including in the United States (specifically Alaska, Illinois, and Ohio) and in numerous international markets such as Argentina, Australia, Canada, and the United Kingdom. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these devices.
The recalled product
- Product
- Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. 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)
- Lots 18845284
- 18845814. Expiration 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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