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.
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 defect that could lead to leaks, representing a risk of harm 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 the Guider Softip XF guide catheter, model H965100430. The recall covers specific lots with expiration dates in late 2018 and 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 numerous international locations.
Healthcare providers and facilities should stop using the affected devices and contact Stryker Neurovascular for instructions on how to return them.
The recalled product
- Product
- Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . 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 (9)
- Lots 18709130
- 18709234
- 18709643
- 18774858
- 18775292
- Expiration 12/31/2019. Lots 18785727
- 18785933
- 18849986
- Expiration 01/31/2019.
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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