Health product recall

Imager™ II Angiographic Catheter

Last updated

Summary

Product
Imager™ II Angiographic Catheter
Issue
Medical devices - Performance
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

Imager II Catheter Straight

74K2400624

M001314011

Imager II Catheter Straight

74G2500421

M001314011

Imager II Catheter Straight

74H2500875

M001314011

Imager II Catheter Straight

74K2400624

M001314031

Imager II Catheter Straight

74G2500421

M001314031

Imager II Catheter Straight

74H2500875

M001314031

Imager II Catheter Straight

74K2400624

M001314001

Imager II Catheter Straight

74G2500421

M001314001

Imager II Catheter Straight

74H2500875

M001314001

Imager II Catheter Straight

74K2400624

M001314021

Imager II Catheter Straight

74G2500421

M001314021

Imager II Catheter Straight

74H2500875

M001314021

Imager II Catheter Bern

More than 10 numbers, contact manufacturer.

M001314101

Imager II Catheter Bern

More than 10 numbers, contact manufacturer.

M001314081

Imager II Catheter Bern

More than 10 numbers, contact manufacturer.

M001314051

Imager II Catheter Bern

More than 10 numbers, contact manufacturer.

M001314061

Imager II Catheter H

74A2600685

M001314141

Imager II Catheter H

74C2500767

M001314141

Imager II Catheter H

74M2500705

M001314141

Imager II Catheter H

74A2600685

M001314151

Imager II Catheter H

74C2500767

M001314151

Imager II Catheter H

74M2500705

M001314151

Imager II Catheter RDC

74K2400620

M001314881

Imager II Catheter RDC

74G2500334

M001314881

Imager II Catheter RDC

74E2500884

M001314881

Imager II Catheter RDC

74G2500226

M001314881

Imager II Catheter C

More than 10 numbers, contact manufacturer.

M001314621

Imager II Catheter C

More than 10 numbers, contact manufacturer.

M001314661

Imager II Catheter C

More than 10 numbers, contact manufacturer.

M001314671

Imager II Catheter SIM

74G2501346

M001314301

Imager II Catheter SIM

74C2500768

M001314301

Imager II Catheter SIM

74B2500492

M001314301

Imager II Catheter SIM

74M2500572

M001314301

Imager II Catheter SIM

74L2401251

M001314301

Imager II Catheter SIM

74L2500032

M001314301

Imager II Catheter SIM

74J2500080

M001314301

Imager II Catheter SIM

74K2400362

M001314301

Imager II Catheter SIM

74C2600733

M001314301

Imager II Catheter SIM

74G2501346

M001314321

Imager II Catheter SIM

74C2500768

M001314321

Imager II Catheter SIM

74B2500492

M001314321

Imager II Catheter SIM

74M2500572

M001314321

Imager II Catheter SIM

74L2401251

M001314321

Imager II Catheter SIM

74L2500032

M001314321

Imager II Catheter SIM

74J2500080

M001314321

Imager II Catheter SIM

74K2400362

M001314321

Imager II Catheter SIM

74C2600733

M001314321

Imager II Catheter SIM

74G2501346

M001314361

Imager II Catheter SIM

74C2500768

M001314361

Imager II Catheter SIM

74B2500492

M001314361

Imager II Catheter SIM

74M2500572

M001314361

Imager II Catheter SIM

74L2401251

M001314361

Imager II Catheter SIM

74L2500032

M001314361

Imager II Catheter SIM

74J2500080

M001314361

Imager II Catheter SIM

74K2400362

M001314361

Imager II Catheter SIM

74C2600733

M001314361

Imager II Catheter SIM

74G2501346

M001314341

Imager II Catheter SIM

74C2500768

M001314341

Imager II Catheter SIM

74B2500492

M001314341

Imager II Catheter SIM

74M2500572

M001314341

Imager II Catheter SIM

74L2500032

M001314341

Imager II Catheter SIM

74J2500080

M001314341

Imager II Catheter SIM

74K2400362

M001314341

Imager II Catheter SIM

74C2600733

M001314341

Imager II Catheter SIM

74L2401251

M001314341

Imager II Catheter SIM

74G2501346

M001314351

Imager II Catheter SIM

74C2500768

M001314351

Imager II Catheter SIM

74B2500492

M001314351

Imager II Catheter SIM

74M2500572

M001314351

Imager II Catheter SIM

74L2401251

M001314351

Imager II Catheter SIM

74L2500032

M001314351

Imager II Catheter SIM

74J2500080

M001314351

Imager II Catheter SIM

74K2400362

M001314351

Imager II Catheter SIM

74C2600733

M001314351

Imager II Catheter MIK

74G2500333

M001314771

Imager II Catheter MIK

74A2501314

M001314771

Imager II Catheter MIK

74D2500883

M001314771

Imager II Catheter MIK

74G2500333

M001314761

Imager II Catheter MIK

74A2501314

M001314761

Imager II Catheter MIK

74D2500883

M001314761

Imager II Catheter Contra 2

74A2600684

M001314581

Imager II Catheter Contra 2

74C2600702

M001314581

Imager II Catheter Contra 2

74K2400616

M001314581

Imager II Catheter Contra 2

74G2500193

M001314581

Imager II Catheter Contra 2

74L2500029

M001314581

Imager II Catheter Contra 2

74K2401117

M001314581

Issue

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. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
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-82589

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