Stryker Neurovascular Recalls Guider Softip XF Guide Catheters
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 hazard is a manufacturing defect leading to potential hub leaks, which is a functional failure rather than a direct, immediate physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or functional defects without reported serious injury.
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of the Guider Softip XF guide catheter (Model M003101500). The recall covers specific lots (18829078, 18831032, 18831033) with an expiration date of January 31, 2019. These 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, Ohio) and numerous international locations.
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/ST XF/6FR/100 cm, Model number:M003101500 . 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 (3)
- Lots 18829078
- 18831032
- 18831033. 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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