Bravo CF capsule delivery devices may have misapplied adhesive causing malfunction
The Bravo CF capsule delivery device is being recalled because misapplied adhesive may prevent the pH capsule attaching to the oesophagus or detaching from the delivery device. 128,202 units affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the oesophagus using endoscopic or manometric guidance, product numbers FGS-0635 (5 pack) and FGS-0636 (1 pack), is being recalled. The action covers 128,202 units.
According to the manufacturer, 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 oesophagus, or from detaching from the delivery device. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the United States and globally. The devices are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product numbers, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by the manufacturer.
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.
- Affected units
- 128,202
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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