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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a defect that could cause temporary or medically reversible health consequences.
Plain-English summary
Stryker Neurovascular is recalling 1,478 units of the Guider Softip XF guide catheter, model number H965100520. The recall covers all models and lot numbers, specifically including Lot 18725364 (expiration 12/31/18) and Lot 18904600 (expiration 02/28/2019). 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 agency has classified this as a Class II recall.
The affected devices were distributed worldwide, including in the United States (Alaska, Illinois, 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 instructions on return or replacement.
The recalled product
- Product
- Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. 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 18725364
- Expiration 12/31/18. Lot 18904600
- Expiration 02/28/2019.
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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