CanadaWhat's being recalled
Companies: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752.
How to identify it
Affected products: OptiCross Coronary Imaging Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: H749518120
Affected products: OptiCross 35 15mhz Peripheral Imaging Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: H7493932800350
Affected products: OptiCross 6 HD; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: H74939354080
Affected products: OptiCross 6 HD; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: H74939354090
Affected products: OptiCross HD; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: H74939352040
Affected products: OptiCross HD; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: H74939352050
Affected products: OptiCross 18 Peripheral Imaging Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: H7493932700180
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States