Health product recall

OptiCross Intravascular Ultrasond Imagine Catheters

Last updated

Summary

Product
OptiCross Intravascular Ultrasond Imagine Catheters
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

OptiCross Coronary Imaging Catheter

More than 10 numbers, contact manufacturer.

H749518120

OptiCross 35 15mhz Peripheral Imaging Catheter

More than 10 numbers, contact manufacturer.

H7493932800350

OptiCross 6 HD

More than 10 numbers, contact manufacturer.

H74939354080

OptiCross 6 HD

More than 10 numbers, contact manufacturer.

H74939354090

OptiCross HD

More than 10 numbers, contact manufacturer.

H74939352040

OptiCross HD

More than 10 numbers, contact manufacturer.

H74939352050

OptiCross 18 Peripheral Imaging Catheter

More than 10 numbers, contact manufacturer.

H7493932700180

Issue

Boston Scientific is providing this advisory regarding the OptiCross™ family of intravascular ultrasound (IVUs) imaging catheters to communicate an update to the flushing instructions, reinforce device preparation and air-management practices, and inform users of upcoming updates to the Instructions For Use (IFU). This advisory applies only to the products listed in attachment 1 from the customer letter.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82877

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