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Trevo microcatheters and synchro devices

Official notice

14 Aug 2024

Last checked

14 Aug 2024

Medium riskHealth Canada
Watch Stryker Neurovascular

An official Health Canada notice concerns Trevo microcatheters and synchro devices. Stryker Neurovascular has distributed multiple lots of Trevo Microcatheters and Synchro devices that did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with American National Standard Bacterial Endotoxins-Test methods, routine monitoring, and alternatives to batch testing AAMI ST72 standard. These lots of Stryker Neurovascular devices may exceed the acceptable limits of endotoxin levels. Recall Start Date: April 29, 2024 Published 2024-08-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75919

Official notice

2024-08-14

The hazard

Stryker Neurovascular has distributed multiple lots of Trevo Microcatheters and Synchro devices that did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with American National Standard Bacterial Endotoxins-Test methods, routine monitoring, and alternatives to batch testing AAMI ST72 standard. These lots of Stryker Neurovascular devices may exceed the acceptable limits of endotoxin levels. Recall Start Date: April 29, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Lots

testing

Recall Numbers

75919

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Affected products

Product 1

Affected products - Trevo Trak 21 Microcatheter, Lot or serial number - 136915 140598 136914 119461 140512 136913, Model or catalog number - 90338

Product 2

Affected products - Trevo Pro 14 Microcatheter, Lot or serial number - 130285 129882, Model or catalog number - 90231

Product 3

Affected products - Synchro Neuro Guidewire, Lot or serial number - 123364 123851, Model or catalog number - M00313010 M00316310

Risk / hazard

Stryker Neurovascular has distributed multiple lots of Trevo Microcatheters and Synchro devices that did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with American National Standard Bacterial Endotoxins-Test methods, routine monitoring, and alternatives to batch testing AAMI ST72 standard. These lots of Stryker Neurovascular devices may exceed the acceptable limits of endotoxin levels. Recall Start Date: April 29, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Stryker Neurovascular, Trevo Microcatheters And Synchro Devices

Manufacturer

Not provided

Phone

Not provided

Brand: Stryker Neurovascular, Trevo Microcatheters And Synchro Devices.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75919

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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