FDA alerts public to Medtronic device recall after 33 injuries
The U.S. Food and Drug Administration (FDA) sent out an alert on Tuesday notifying the public of an issue with Medtronic pH monitoring capsules. These are placed in the esophagus to record data and help a physician in diagnosing acid reflux erosion.
The Bravo CF capsules subject to this notice have a manufacturing defect, causing them to detach from the delivery device. This could put patients at serious risk of aspiration and perforation of the esophagus, leading to a host of other complications, in addition to delaying any diagnosis.
Medtronic and its subsidiary Given Imaging have sent urgent letters to customers, warning them to stop using capsules from certain lots. While no deaths have been reported, 33 patients are known to have been injured as a result of the issue.
Early alert and limited recall
The FDA sent this notice as part of its communication pilot to make device recalls more timely and effective. To comply, certain Bravo CF capsules must be identified and removed from the supply chain, be it at provider clinics or in dealer inventory.
Impacted lots include the following:
Product Name | Product Number | UDI-DI |
Bravo CF Capsule Delivery Device, 5-pk | FGS-0635 | 07290101369707 |
Bravo CF Capsule Delivery Device, 5-pk | FGS-0635 | 10613994000009 |
Bravo CF Capsule Delivery Device, 1-pk | FGS-0636 | 07290101369714 |
This information can be found on the packaging. Medtronic has provided an image to help match affected product numbers.
Next steps
Customers should have received an Urgent Medical Device Recall letter from Medtronic on June 3. Within, it instructs anyone in possession to immediately identify Bravo capsules with the manufacturing defect and quarantine them, before they can be accidentally used in patient care.
Replacement or credit can be received by contacting Medtronic at 800-448-3644, Option 3. To effectuate the removal of the devices from supply, the company and the FDA ask that this recall notice be displayed and shared.
The FDA said it will continue to update the public about the issues, in case the recall expands to other lots. The full alert can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.