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)
Reported: July 16, 2025 Initiated: June 3, 2025 #Z-2047-2025
Product Description
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)
Reason for Recall
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.
Details
- Recalling Firm
- Given Imaging Ltd.
- Units Affected
- 128,202 units
- Distribution
- US Nationwide. Global Distribution.
- Location
- Yokne'Am Ilit, N/A
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Given Imaging Ltd.. Units affected: 128,202 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2025. Severity: Critical. Recall number: Z-2047-2025.
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