Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide 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 FDA classified this as a Class II recall for a medical device with a potential for adverse health consequences (hub leaks) but without reported fatalities or serious injuries, aligning with the 'High' severity criteria 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 and GUIDER MPXF 5F 100CM guide catheters, model number M003101630. The recall covers all models and lot numbers, specifically including Lot 18753510 (expiration 12/31/18) and Lot 18847876 (expiration 01/31/2019). 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 FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected devices were distributed worldwide, including in the United States (Alaska, Illinois, and Ohio) and internationally to numerous countries such as Argentina, Australia, Brazil, Canada, France, Germany, Japan, and the United Kingdom. Healthcare providers and facilities should stop using these devices and contact Stryker Neurovascular for instructions on return or replacement.
The recalled product
- Product
- Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. 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 18753510
- Expiration 12/31/18. Lot 18847876
- 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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