CanadaWhat's being recalled
Companies: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752.
How to identify it
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195500
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195420
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195450
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195430
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195440
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195510
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195480
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195400
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195410
Affected products: Direxion Hi-Flo Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195470
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195260
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195290
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195220
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195230
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195250
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195300
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195330
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195340
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195350
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195200
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195240
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195270
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195310
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195210
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195320
Affected products: Direxion Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195280
Affected products: Direxion Hi-Flo Transend-18 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195910
Affected products: Direxion Hi-Flo Transend-18 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195940
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38687335; Model or catalogue number: M001195840
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 37957749; Model or catalogue number: M001195840
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38350332; Model or catalogue number: M001195840
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 39187259; Model or catalogue number: M001195840
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38629563; Model or catalogue number: M001195840
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38181980; Model or catalogue number: M001195840
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38649510; Model or catalogue number: M001195840
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 40512912; Model or catalogue number: M001195840
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 39074451; Model or catalogue number: M001195840
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38687335; Model or catalogue number: M001195810
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 37957749; Model or catalogue number: M001195810
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38350332; Model or catalogue number: M001195810
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 39187259; Model or catalogue number: M001195810
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38629563; Model or catalogue number: M001195810
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38181980; Model or catalogue number: M001195810
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38649510; Model or catalogue number: M001195810
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 40512912; Model or catalogue number: M001195810
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 39074451; Model or catalogue number: M001195810
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38687335; Model or catalogue number: M001195850
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 37957749; Model or catalogue number: M001195850
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38350332; Model or catalogue number: M001195850
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 39187259; Model or catalogue number: M001195850
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38629563; Model or catalogue number: M001195850
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38181980; Model or catalogue number: M001195850
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38649510; Model or catalogue number: M001195850
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 40512912; Model or catalogue number: M001195850
Affected products: Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 39074451; Model or catalogue number: M001195850
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38445016; Model or catalogue number: M001195710
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38273638; Model or catalogue number: M001195710
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 40485616; Model or catalogue number: M001195710
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38416365; Model or catalogue number: M001195710
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38445016; Model or catalogue number: M001195720
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38273638; Model or catalogue number: M001195720
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 40485616; Model or catalogue number: M001195720
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38416365; Model or catalogue number: M001195720
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38445016; Model or catalogue number: M001195740
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38273638; Model or catalogue number: M001195740
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 40485616; Model or catalogue number: M001195740
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38416365; Model or catalogue number: M001195740
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38445016; Model or catalogue number: M001195750
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38273638; Model or catalogue number: M001195750
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 40485616; Model or catalogue number: M001195750
Affected products: Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: 38416365; Model or catalogue number: M001195750
Affected products: Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195670
Affected products: Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195620
Affected products: Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001195610
Affected products: Direxion Fathom-16 System Pre-Loaded Torqueable
The hazard
Boston scientific is initiating the removal of specific lots of Direxion and Direxion HI-FLO Microcatheters due to a manufacturing issue that may cause difficulty withdrawing the device from the carrier hoop and difficulty advancing or withdrawing the device through a guide catheter.
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