CanadaBoston Scientific Corporation’s Imager II Angiographic Catheters (various Straight, Bern and H configurations) are affected; check product model/catalogue numbers such as M001314011, M001314031, M001314001, M001314021, M001314101, M001314081, M001314051, M001314061 and M001314141 and lot/serial numbers including 74K2400624, 74G2500421, 74H2500875, 74A2600685, 74C2500767 and 74M2500705 (Bern lots list “more than 10 numbers,” contact manufacturer). Boston Scientific is removing these devices because reduced stabilizing agents in catheter tips may increase the risk of tip degradation and detachment. Contact the manufacturer for additional information.
What's being recalled
Companies: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752.
How to identify it
Affected products: Imager II Catheter Straight; Lot or serial number: 74K2400624; Model or catalogue number: M001314011
Affected products: Imager II Catheter Straight; Lot or serial number: 74G2500421; Model or catalogue number: M001314011
Affected products: Imager II Catheter Straight; Lot or serial number: 74H2500875; Model or catalogue number: M001314011
Affected products: Imager II Catheter Straight; Lot or serial number: 74K2400624; Model or catalogue number: M001314031
Affected products: Imager II Catheter Straight; Lot or serial number: 74G2500421; Model or catalogue number: M001314031
Affected products: Imager II Catheter Straight; Lot or serial number: 74H2500875; Model or catalogue number: M001314031
Affected products: Imager II Catheter Straight; Lot or serial number: 74K2400624; Model or catalogue number: M001314001
Affected products: Imager II Catheter Straight; Lot or serial number: 74G2500421; Model or catalogue number: M001314001
Affected products: Imager II Catheter Straight; Lot or serial number: 74H2500875; Model or catalogue number: M001314001
Affected products: Imager II Catheter Straight; Lot or serial number: 74K2400624; Model or catalogue number: M001314021
Affected products: Imager II Catheter Straight; Lot or serial number: 74G2500421; Model or catalogue number: M001314021
Affected products: Imager II Catheter Straight; Lot or serial number: 74H2500875; Model or catalogue number: M001314021
Affected products: Imager II Catheter Bern; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001314101
Affected products: Imager II Catheter Bern; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001314081
Affected products: Imager II Catheter Bern; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001314051
Affected products: Imager II Catheter Bern; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001314061
Affected products: Imager II Catheter H; Lot or serial number: 74A2600685; Model or catalogue number: M001314141
Affected products: Imager II Catheter H; Lot or serial number: 74C2500767; Model or catalogue number: M001314141
Affected products: Imager II Catheter H; Lot or serial number: 74M2500705; Model or catalogue number: M001314141
Affected products: Imager II Catheter H; Lot or serial number: 74A2600685; Model or catalogue number: M001314151
Affected products: Imager II Catheter H; Lot or serial number: 74C2500767; Model or catalogue number: M001314151
Affected products: Imager II Catheter H; Lot or serial number: 74M2500705; Model or catalogue number: M001314151
Affected products: Imager II Catheter RDC; Lot or serial number: 74K2400620; Model or catalogue number: M001314881
Affected products: Imager II Catheter RDC; Lot or serial number: 74G2500334; Model or catalogue number: M001314881
Affected products: Imager II Catheter RDC; Lot or serial number: 74E2500884; Model or catalogue number: M001314881
Affected products: Imager II Catheter RDC; Lot or serial number: 74G2500226; Model or catalogue number: M001314881
Affected products: Imager II Catheter C; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001314621
Affected products: Imager II Catheter C; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001314661
Affected products: Imager II Catheter C; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M001314671
Affected products: Imager II Catheter SIM; Lot or serial number: 74G2501346; Model or catalogue number: M001314301
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2500768; Model or catalogue number: M001314301
Affected products: Imager II Catheter SIM; Lot or serial number: 74B2500492; Model or catalogue number: M001314301
Affected products: Imager II Catheter SIM; Lot or serial number: 74M2500572; Model or catalogue number: M001314301
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2401251; Model or catalogue number: M001314301
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2500032; Model or catalogue number: M001314301
Affected products: Imager II Catheter SIM; Lot or serial number: 74J2500080; Model or catalogue number: M001314301
Affected products: Imager II Catheter SIM; Lot or serial number: 74K2400362; Model or catalogue number: M001314301
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2600733; Model or catalogue number: M001314301
Affected products: Imager II Catheter SIM; Lot or serial number: 74G2501346; Model or catalogue number: M001314321
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2500768; Model or catalogue number: M001314321
Affected products: Imager II Catheter SIM; Lot or serial number: 74B2500492; Model or catalogue number: M001314321
Affected products: Imager II Catheter SIM; Lot or serial number: 74M2500572; Model or catalogue number: M001314321
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2401251; Model or catalogue number: M001314321
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2500032; Model or catalogue number: M001314321
Affected products: Imager II Catheter SIM; Lot or serial number: 74J2500080; Model or catalogue number: M001314321
Affected products: Imager II Catheter SIM; Lot or serial number: 74K2400362; Model or catalogue number: M001314321
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2600733; Model or catalogue number: M001314321
Affected products: Imager II Catheter SIM; Lot or serial number: 74G2501346; Model or catalogue number: M001314361
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2500768; Model or catalogue number: M001314361
Affected products: Imager II Catheter SIM; Lot or serial number: 74B2500492; Model or catalogue number: M001314361
Affected products: Imager II Catheter SIM; Lot or serial number: 74M2500572; Model or catalogue number: M001314361
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2401251; Model or catalogue number: M001314361
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2500032; Model or catalogue number: M001314361
Affected products: Imager II Catheter SIM; Lot or serial number: 74J2500080; Model or catalogue number: M001314361
Affected products: Imager II Catheter SIM; Lot or serial number: 74K2400362; Model or catalogue number: M001314361
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2600733; Model or catalogue number: M001314361
Affected products: Imager II Catheter SIM; Lot or serial number: 74G2501346; Model or catalogue number: M001314341
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2500768; Model or catalogue number: M001314341
Affected products: Imager II Catheter SIM; Lot or serial number: 74B2500492; Model or catalogue number: M001314341
Affected products: Imager II Catheter SIM; Lot or serial number: 74M2500572; Model or catalogue number: M001314341
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2500032; Model or catalogue number: M001314341
Affected products: Imager II Catheter SIM; Lot or serial number: 74J2500080; Model or catalogue number: M001314341
Affected products: Imager II Catheter SIM; Lot or serial number: 74K2400362; Model or catalogue number: M001314341
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2600733; Model or catalogue number: M001314341
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2401251; Model or catalogue number: M001314341
Affected products: Imager II Catheter SIM; Lot or serial number: 74G2501346; Model or catalogue number: M001314351
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2500768; Model or catalogue number: M001314351
Affected products: Imager II Catheter SIM; Lot or serial number: 74B2500492; Model or catalogue number: M001314351
Affected products: Imager II Catheter SIM; Lot or serial number: 74M2500572; Model or catalogue number: M001314351
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2401251; Model or catalogue number: M001314351
Affected products: Imager II Catheter SIM; Lot or serial number: 74L2500032; Model or catalogue number: M001314351
Affected products: Imager II Catheter SIM; Lot or serial number: 74J2500080; Model or catalogue number: M001314351
Affected products: Imager II Catheter SIM; Lot or serial number: 74K2400362; Model or catalogue number: M001314351
Affected products: Imager II Catheter SIM; Lot or serial number: 74C2600733; Model or catalogue number: M001314351
Affected products: Imager II Catheter MIK; Lot or serial number: 74G2500333; Model or catalogue number: M001314771
Affected products: Imager II Catheter MIK; Lot or serial number: 74A2501314; Model or catalogue number: M001314771
Affected products: Imager II Catheter MIK; Lot or serial number: 74D2500883; Model or catalogue number: M001314771
Affected products: Imager II Catheter MIK; Lot or serial number: 74G2500333; Model or catalogue number: M001314761
Affected products: Imager II Catheter MIK; Lot or serial number: 74A2501314; Model or catalogue number: M001314761
Affected products: Imager II Catheter MIK; Lot or serial number: 74D2500883; Model or catalogue number: M001314761
Affected products: Imager II Catheter Contra 2; Lot or serial number: 74A2600684; Model or catalogue number: M001314581
Affected products: Imager II Catheter Contra 2; Lot or serial number: 74C2600702; Model or catalogue number: M001314581
Affected products: Imager II Catheter Contra 2; Lot or serial number: 74K2400616; Model or catalogue number: M001314581
Affected products: Imager II Catheter Contra 2; Lot or serial number: 74G2500193; Model or catalogue number: M001314581
Affected products: Imager II Catheter Contra 2; Lot or serial number: 74L2500029; Model or catalogue number: M001314581
Affected products: Imager II Catheter Contra 2; Lot or serial number: 74K2401117; Model or catalogue number: M001314581
The hazard
Boston Scientific is initiating removal of Imager II Angiographic Catheters (“Catheters”) due to a manufacturing issue affecting the catheter tip. This removal affects the devices identified in Attachment 1 of the customer letter. Boston Scientific has determined that these Catheters were manufactured with reduced levels of stabilizing agents in the tips. This may increase the risk of tip degradation and detachment.
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