Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks in the devices.
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 is classified as FDA Class II, and the source text identifies a risk-of-harm product (medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of Guider Softip XF guide catheters, specifically the GUIDER 40XF 5F 90CM model (Model number M003100620). The recall covers lots 18932470 and 18932472, which have an expiration date of February 28, 2019.
The recall was initiated because the firm identified a manufacturing non-conformance that could lead to hub leaks in the resulting product. 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 (Alaska, Illinois, and Ohio) and internationally to numerous countries such as Argentina, Australia, Canada, France, Germany, Japan, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Catheter
- 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 18932470
- 18932472. Expiration .2/28/2019
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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