Health product recall

Direxion and Direxion HI-FLO Microcatheters

Brand(s)
BOSTON SCIENTIFIC CORPORATION
Last updated

Summary

Product
Direxion and Direxion HI-FLO Microcatheters
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

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
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-82710

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Date modified: