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