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
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. The hazard involves a manufacturing defect leading to hub leaks in a medical device used for neurovascular procedures, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of the Guider Softip XF guide catheter, specifically the GUIDER/40 DEG XF/7FR/100 cm model (Model number M003101430). 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 units include Lot 18786335, 18790229, and 18790450 (expiration 12/31/2018) and Lot 18851082 (expiration 1/31/2019).
The 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/40 DEG XF/7FR/100 cm, Model number: M003101430 . 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)
- Lot 18786335
- 18790229
- 18790450. Expiration 12/31/2018. Lot 18851082. 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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