Orbera Intragastric Balloon System (2019-07-18)
- Starting date:
- July 18, 2019
- Posting date:
- August 2, 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-70595
Last updated: 2019-08-02
Affected Products
Orbera Intragastric Balloon System
Reason
TGA advised Apollo to include new safety information related to adverse event types, gastric perforation and aspiration, that were previously not listed in the instructions for use.
Affected products
Orbera Intragastric Balloon System
Lot or serial number
All lots.
Model or catalog number
B-50000
B40800
Companies
- Manufacturer
-
APOLLO ENDOSURGERY, INC.
1120 S Capital Of Texas HWY., Building 1, Suite 300
Austin
78746
Texas
UNITED STATES