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:

Affected Products

  1. LINEAR INTRA-AORTIC BALLOON CATHETER WITH INSERTION KIT
  2. SENSATION INTRA-AORTIC BALLOON CATHETER DATASCOPE EXTEND. W/INS. KIT/INTRO.
  3. 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