Quick summary
Quick summary: OptiCross Intravascular Ultrasond Imagine Catheters. Reason: Health product recall. Category: Health products. Date: 2026-10-29.
Public recall detail
OptiCross Intravascular Ultrasond Imagine Catheters
2026-10-29
Health products
Health product recall
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: OptiCross Intravascular Ultrasond Imagine Catheters. Reason: Health product recall. Category: Health products. Date: 2026-10-29.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandBOSTON SCIENTIFIC CORPORATION
ProductOptiCross Intravascular Ultrasond Imagine Catheters
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-82877
Affected products
ProductOptiCross Coronary Imaging Catheter
LotMore than 10 numbers, contact manufacturer.
ModelH749518120
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionOptiCross Coronary Imaging Catheter
ProductOptiCross 35 15mhz Peripheral Imaging Catheter
LotMore than 10 numbers, contact manufacturer.
ModelH7493932800350
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionOptiCross 35 15mhz Peripheral Imaging Catheter
ProductOptiCross 6 HD
LotMore than 10 numbers, contact manufacturer.
ModelH74939354080
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionOptiCross 6 HD
ProductOptiCross 6 HD
LotMore than 10 numbers, contact manufacturer.
ModelH74939354090
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionOptiCross 6 HD
ProductOptiCross HD
LotMore than 10 numbers, contact manufacturer.
ModelH74939352040
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionOptiCross HD
ProductOptiCross HD
LotMore than 10 numbers, contact manufacturer.
ModelH74939352050
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionOptiCross HD
ProductOptiCross 18 Peripheral Imaging Catheter
LotMore than 10 numbers, contact manufacturer.
ModelH7493932700180
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionOptiCross 18 Peripheral Imaging Catheter
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.
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesBoston Scientific Corporation 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Recall date2026-10-22
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82877
Background{}
CompaniesBoston Scientific Corporation 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
AudiencesHealthcare
Source updated2026-10-29
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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