Given Imaging Ltd.
2 Hacarmel St., Yoqneam Northern, IL
Registered product codes
6 product codes
Recent MDR events
11,035 on file
- BravoJul 31, 2026Malfunction9710107-2026-00357
- BravoJul 31, 2026Malfunction9710107-2026-00358
- BravoJul 31, 2026Malfunction9710107-2026-00359
- PillCamJul 28, 2026Injury9710107-2026-00355
- PillCamJul 28, 2026Injury9710107-2026-00356
- BRAVOJul 21, 2026Malfunction9710107-2026-00352
- BRAVOJul 21, 2026Malfunction9710107-2026-00353
- BRAVOJul 21, 2026Injury9710107-2026-00354
- BRAVOJul 17, 2026Malfunction9710107-2026-00345
- BRAVOJul 17, 2026Malfunction9710107-2026-00346
Recalls
3 on file
- Open, ClassifiedJul 10, 2025
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
View FDA record ↗ - TerminatedFeb 6, 2012
Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device.
View FDA record ↗ - TerminatedMar 23, 2011
The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.
View FDA record ↗
Compliance history
Matched by FEI 3003348376.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.