Recall MonitorHealth Products
Imager™ II Angiographic Catheter
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Imager™ II Angiographic Catheter
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.