Given Imaging Recalls Bravo CF Capsule Delivery Devices Due to Attachment Failure
Given Imaging is recalling Bravo CF capsule delivery devices because they may fail to attach to the esophagus or detach from the device, posing risks of aspiration and perforation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of serious physical harm, including esophageal perforation and airway obstruction, but the source text does not report any specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Given Imaging Ltd. is recalling Bravo CF capsule delivery devices, specifically the 5-pack (Product Number FGS-0635) and 1-pack (Product Number FGS-0636). These devices are used to attach a pH monitoring capsule to the esophagus. The recall covers 127,416 units with expiration dates prior to and including October 20, 2027, and lot numbers from 64553F up to and including 68912F.
The recall was initiated because the capsule may fail to attach to the esophagus or detach from the delivery device. This malfunction presents risks including patient aspiration or inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage or blood loss, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
The affected devices were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as in numerous international markets such as Argentina, Australia, Canada, China, France, Germany, India, and the United Kingdom. Consumers and healthcare providers should stop using the affected devices and contact Given Imaging Ltd. for further instructions.
The recalled product
- Product
- Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.
- Manufacturer
- Given Imaging Ltd.
- Affected units
- 127,416
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 (1)
- 2027 (lot numbers from 64553F up to and including 68912F)
Distribution
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