INTRA-AORTIC BALLOON CATHETERS (2020-08-28)
- Starting date:
- August 28, 2020
- Posting date:
- September 11, 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-73895
Last updated:
2020-09-11
Affected Products
- LINEAR INTRA-AORTIC BALLOON CATHETER WITH INSERTION KIT
- SENSATION INTRA-AORTIC BALLOON CATHETER DATASCOPE EXTEND. W/INS. KIT/INTRO.
- MEGA 8FR. INTRA-AORTIC BALLOON CATHETER
Reason
Certain Intra-Aortic Balloon Catheters (IABS) may not meet the requirement for endotoxin per AAMI ST72. Datascope/getinge performs functional testing on a small number of units from every lot prior to sterilization and these functionally-tested units may pose an elevated risk of endotoxin contamination compared to normal production IABS. These functionally-tested units can be identified by serial number and represent less than 1% of total IABS distributed in this timeframe.
Affected products
A. LINEAR INTRA-AORTIC BALLOON CATHETER WITH INSERTION KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 0684-00-0478-01
- 0684-00-0478-02
- 0684-00-0479-01
- 0684-00-0479-02
- 0684-00-0480-01
- 0684-00-0480-02
Companies
- Manufacturer
-
Datascope Corp.,
15 Law Drive,
Fairfield
07004
New Jersey
UNITED STATES
B. SENSATION INTRA-AORTIC BALLOON CATHETER DATASCOPE EXTEND. W/INS. KIT/INTRO.
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 0684-00-0469-01
- 0684-00-0470-01
Companies
- Manufacturer
-
Datascope Corp.,
15 Law Drive,
Fairfield
07004
New Jersey
UNITED STATES
C. MEGA 8FR. INTRA-AORTIC BALLOON CATHETER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 0684-00-0296-01
Companies
- Manufacturer
-
Datascope Corp.,
15 Law Drive,
Fairfield
07004
New Jersey
UNITED STATES