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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4).
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of the Guider Softip XF guide catheter, specifically the GUIDER/MP XF/6FR/90CM model (Model number: H965100460). The affected lots are 18716056, 18752458, and 18752804, all with an expiration date of 12/31/18. 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 agency has classified this as a Class II recall.
The devices were distributed worldwide, including in the United States (Alaska, Illinois, and Ohio) and internationally to numerous countries such as Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Japan, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UK, Uruguay, and Vietnam. Healthcare providers should stop using the affected devices and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. 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: 18716056
- 18752458
- 18752804. Expiration 12/31/18.
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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