Bravo CF capsule delivery device recalled for misapplied adhesive defect
Given Imaging's Bravo CF capsule delivery device is recalled due to misapplied adhesive that may prevent the pH monitoring capsule from attaching to the esophagus or detaching from the delivery device. The recall affects 128,202 units distributed nationwide and globally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for a medical device. The misapplied adhesive poses risk of device malfunction during diagnostic use, although no adverse health outcomes have been reported to date.
Plain-English summary
Given Imaging Ltd. is recalling the Bravo CF capsule delivery device (Product Numbers FGS-0635, 5-pack, and FGS-0636, 1-pack), a medical device used in clinical settings to place and attach a pH monitoring capsule to the esophagus during endoscopic or manometric procedures. The recall affects 128,202 units with distribution throughout the United States and internationally.
The recall was initiated due to misapplied adhesive on affected devices. This manufacturing defect may prevent the pH monitoring capsule from attaching to the patient's esophagus, or may prevent it from detaching from the delivery device.
This is a Class I FDA recall. The specific lot numbers of affected devices are detailed in the official FDA recall notice.
The recalled product
- Product
- 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)
- Manufacturer
- Given Imaging Ltd.
- Hazard
- adhesive-defect
- attachment-failure
- detachment-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- FGS-0635: UDI-DI: 07290101369707
- FGS-0636: UDI-DI: 07290101369714
Distribution
Distributed nationwide across the United States.
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