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Syntel silicone thrombectomy catheter

Official notice

18 Apr 2024

Last checked

18 Apr 2024

Medium riskHealth Canada

An official Health Canada notice concerns Syntel silicone thrombectomy catheter. It has been reported that during the use of the Syntel Silicone Thrombectomy Catheter, the guide tip (not the balloon or catheter) can become damaged and result in the tip detaching. Recall start date: April 10, 2024 Published 2024-04-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75406

Official notice

2024-04-18

The hazard

It has been reported that during the use of the Syntel Silicone Thrombectomy Catheter, the guide tip (not the balloon or catheter) can become damaged and result in the tip detaching. Recall start date: April 10, 2024

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

75406

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Affected products

Product 1

Affected lots - Syntel Silicone Thrombectomy Catheter, Lot or serial number - SST1064 SST1067 SST1063 SST1066 SST1031, Model or catalogue number - A4558 A5568 A4548 A4554

Risk / hazard

It has been reported that during the use of the Syntel Silicone Thrombectomy Catheter, the guide tip (not the balloon or catheter) can become damaged and result in the tip detaching. Recall start date: April 10, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Lemaitre Vascular, Syntel Silicone Thrombectomy Catheter.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75406

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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