Imager II Angiographic Catheters - 5F Curved Tip Shapes (2020-08-04)
- Starting date:
- August 4, 2020
- Posting date:
- October 9, 2020
- 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-74095
Last updated:
2020-10-09
Affected Products
A. IMAGER II/5/BERN/100/038 BX5
B. IMAGER II/5/H1/100/035 BX 5
C. IMAGER II/5/JB1/65/038 BX5
D. IMAGER II/5/SIM1/100/038 BX5
E. IMAGER II/5/CHG2.5/65/038 BX5
F. IMAGER II/5/CONTRA 2/65/035 BX 5
G. IMAGER II CATHETER C
H. IMAGER II/5/MIK/65/038 BX5
I. IMAGER II/5/HK1.0/65/035 BX 5
J. IMAGER II CATHETER SHK
K. IMAGER II/5/RC1/65/038 BX5
L. IMAGER II/5/TENNIS RACQUET/65/038 BX5
M. IMAGER II/5/PIGTAIL/100/035 BX5
N. IMAGER II/5/CONTRALATERAL/65/035 BX5
Reason
We have identified an increase in the rate of tip detachment complaints on the 5F curve tip shapes configuration. Investigation has now concluded the need to expand the scope to all lots/batches of the 5F curved tip shapes of the Imager II Angiographic Catheters. There have been three patient injuries reported since the initial removal of product earlier this year.
Affected products
A. IMAGER II/5/BERN/100/038 BX5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-405
31-406
31-407
31-408
31-409
31-410
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
B. IMAGER II/5/H1/100/035 BX 5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-415
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
C. IMAGER II/5/JB1/65/038 BX5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-421
31-423
31-425
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
D. IMAGER II/5/SIM1/100/038 BX5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-430
31-431
31-432
31-433
31-435
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
E. IMAGER II/5/CHG2.5/65/038 BX5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-456
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
F. IMAGER II/5/CONTRA 2/65/035 BX 5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-458
31-459
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
G. IMAGER II CATHETER C
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-462
31-463
31-466
31-467
31-468
31-470
31-471
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
H. IMAGER II/5/MIK/65/038 BX5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-476
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
I. IMAGER II/5/HK1.0/65/035 BX 5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-478
31-479
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
J. IMAGER II CATHETER SHK
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-480
31-481
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
K. IMAGER II/5/RC1/65/038 BX5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-484
31-485
31-486
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
L. IMAGER II/5/TENNIS RACQUET/65/038 BX5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-506
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
M. IMAGER II/5/PIGTAIL/100/035 BX5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-513
31-514
31-515
31-519
31-521
31-523
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES
N. IMAGER II/5/CONTRALATERAL/65/035 BX5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-528
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES