Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that 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 is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of the Guider Softip XF guide catheter, specifically the GUIDER/40XF/8FR/90CM model (Model number H965100440). The recall covers specific lots with expiration dates ranging from January 31, 2019, to March 31, 2019.
The recall was initiated because the firm identified a manufacturing non-conformance that could result in hub leaks in the catheter. These devices 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 in numerous international markets such as Canada, the United Kingdom, and Germany. Healthcare providers should stop using the affected devices and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . 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 (6)
- Lots 18775812
- 18775993
- Expiration 01/31/19. Lot 18904219
- Expiration 02/28/2019
- Lots 19025649
- 19025651. Expiration 03/31/2019.
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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