Recall MonitorHealth Products
Direxion and Direxion HI-FLO Microcatheters
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Direxion and Direxion HI-FLO Microcatheters
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 |
|---|---|---|
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195500 |
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195420 |
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195450 |
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195430 |
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195440 |
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195510 |
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195480 |
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195400 |
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195410 |
| Direxion Hi-Flo Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195470 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195260 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195290 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195220 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195230 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195250 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195300 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195330 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195340 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195350 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195200 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195240 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195270 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195310 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195210 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195320 |
| Direxion Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195280 |
| Direxion Hi-Flo Transend-18 System Pre-Loaded Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195910 |
| Direxion Hi-Flo Transend-18 System Pre-Loaded Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195940 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38687335 | M001195840 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 37957749 | M001195840 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38350332 | M001195840 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 39187259 | M001195840 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38629563 | M001195840 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38181980 | M001195840 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38649510 | M001195840 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 40512912 | M001195840 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 39074451 | M001195840 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38687335 | M001195810 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 37957749 | M001195810 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38350332 | M001195810 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 39187259 | M001195810 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38629563 | M001195810 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38181980 | M001195810 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38649510 | M001195810 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 40512912 | M001195810 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 39074451 | M001195810 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38687335 | M001195850 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 37957749 | M001195850 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38350332 | M001195850 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 39187259 | M001195850 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38629563 | M001195850 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38181980 | M001195850 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 38649510 | M001195850 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 40512912 | M001195850 |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | 39074451 | M001195850 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38445016 | M001195710 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38273638 | M001195710 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 40485616 | M001195710 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38416365 | M001195710 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38445016 | M001195720 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38273638 | M001195720 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 40485616 | M001195720 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38416365 | M001195720 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38445016 | M001195740 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38273638 | M001195740 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 40485616 | M001195740 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38416365 | M001195740 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38445016 | M001195750 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38273638 | M001195750 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 40485616 | M001195750 |
| Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter | 38416365 | M001195750 |
| Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195670 |
| Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195620 |
| Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195610 |
| Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195640 |
| Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195650 |
| Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter | More than 10 numbers, contact manufacturer. | M001195660 |
Issue
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.