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BRAVO - CAPSULE DELIVERY SYS (2016-04-19)
- Starting date:
- April 19, 2016
- Posting date:
- May 16, 2016
- 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-58350
Affected products
- BRAVO - CAPSULE DELIVERY SYS
Reason
Three reports were received from customers related to patients having allergic reactions to the nickel content in the Stainless Steel Trocar Needle that attaches the Bravo capsule to the esophageal mucosa. Allergic reactions can include hives, itching or oral numbness. There have been no reports of serious injury related to this safety notice.
Affected products
-
BRAVO - CAPSULE DELIVERY SYS
Lot or serial number
All lots
Model or catalog number
- FGS-0312
- FGS-0313
Companies
- Manufacturer
-
GIVEN IMAGING INC,
3950 SHACKLEFORD ROAD SUITE 500
DULUTH
30096
Georgia
UNITED STATES