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The US Food and Drug Administration (FDA) has issued an early alert for three Medtronic pH-monitoring capsule devices. The notice follows two letters sent in June to customers by the devices’ manufacturer Medtronic and its subsidiary Given Imaging Inc., recommending that customers using certain Bravo CF Capsule Delivery Devices (lot numbers below) for esophageal pH monitoring be removed from all sites of use and sale.
All three of the capsule models listed below are thought to pose a potential risk because the capsules fail to attach to the esophagus’s mucosal wall or to detach from the delivery device as intended owing to a misapplication of adhesive during manufacture. The devices transmit pH data to a recorder attached to the waist of the patient, who interacts with the recorder to indicate symptoms, thereby allowing the physician to compare the symptoms with the occurrence of reflux episodes.
Risks associated with the devices include aspiration/inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
Medtronic has reported 33 serious injuries but no deaths associated with the devices.
The lot numbers of the three affected units, which should be identified and quarantined immediately are:
- Bravo CF Capsule Delivery Device, 5-pk, Product Number FGS-0635, Unique Device Identifier-Device Identifier (UDI-DI) 07290101369707
- Bravo CF Capsule Delivery Device 5-pk, FGS-0635, UDI-DI 10613994000009
- Bravo CF Capsule Delivery Device 1-pk, FGS-0636, UDI-DI 07290101369714
These lot identifiers can be found on both the 5-pks’ FGS-0635 outer labels and on the 1-pk FGS-036 individual unit. Customers are advised to return all unused affected products to Medtronic for replacement or credit. In addition, they should pass on this notice to all those who need to be aware within their organizations or to any organizations to which the affected products have been distributed.
They are also advised to check the FDA recall website above for updates as it continues to review information about this potentially high-risk device issue.
Healthcare professionals with concerns or reports of adverse events can contact Medtronic at 800-448-3644 or MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
