Health product recall

Azur CX Peripheral Coil System (2019-11-26)

Starting date:
November 26, 2019
Posting date:
December 13, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71871



Last updated: 2019-12-13

Affected Products

  1. Azur Peripheral Hydrocoil - Detachable
  2. Azur CX Peripheral Hydrocoil - Detachable 18
  3. Azur CX Peripheral Coil System - Detachable 35

Reason

Complaints were received for the embolization coil devices where the coil was missing.

Affected products

  1. Azur Peripheral Hydrocoil - Detachable

Lot or serial number

190320539

19032053A

Model or catalog number

45-481520

45-482020

Companies
Manufacturer

Microvention Inc.

1311 Valencia Ave

Tustin

92780

California

UNITED STATES


B. Azur CX Peripheral Hydrocoil - Detachable 18

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

45-780204

45-780304

45-780308

45-780413

45-780516

45-780620

45-780724

45-780828

45-781032

45-781836

Companies
Manufacturer

Microvention Inc.

1311 Valencia Ave

Tustin

92780

California

UNITED STATES


C. Azur CX Peripheral Coil System - Detachable 35

Lot or serial number

1903045J2

1904225J2

1904265J2

1904295J2

Model or catalog number

45-750511

45-750824

45-751019

45-751324

45-751632

45-752039

Companies
Manufacturer

Microvention Inc.

1311 Valencia Ave

Tustin

92780

California

UNITED STATES