Given Imaging Ltd.
FDA adverse event reports naming Given Imaging Ltd. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: GIVEN IMAGING LTD..
- Total reports
- 4,963
- Deaths
- 5
- Injuries
- 61
- Malfunctions
- 4,891
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2025-07-10Open, ClassifiedProcess control
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
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.
- 2012-02-06TerminatedNonconforming Material/Component
Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313). Product Usage: The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry.
Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device.
- 2011-03-23TerminatedDevice Design
Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).
The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.
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