Stryker Neurovascular Recalls Synchro2 Soft Guidewires for Sterility Concerns

Plain-English summary

Stryker Neurovascular has initiated a voluntary recall of 831 units of Synchro2, 0.014in x 300cm SOFT Guidewires with Hydrophilic Coating. The product is intended for general intravascular use, including neurovascular and peripheral vasculatures. The recall was initiated on June 8, 2018, and was classified as Class II by the FDA.

The reason for the recall is a potential loss of sterility. The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. The recall status is currently terminated as of April 28, 2021.

Healthcare providers and facilities should check their inventory for the specific lot numbers and UDI codes listed in the recall documentation. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific consumer action is required for the general public, as this is a professional medical device.

The recalled product

Product

Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Manufacturer

Stryker Neurovascular

Category

Medical Device — Interventional Cardiology / Neurovascular

Hazard

• loss-of-sterility
• infection-risk

Affected units

831

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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