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Medtronic recalls capsule delivery devices due to 33 reported severe incidents

FDA posts early warning for product recall on Tuesday, with no reported fatalities linked to the issue.

Medtronic recalls capsule delivery devices linked to 33 severe complications
Medtronic recalls capsule delivery devices linked to 33 severe complications

Medtronic recalls capsule delivery devices due to 33 reported severe incidents

The Food and Drug Administration (FDA) has announced a Class I recall for the Bravo capsule delivery devices manufactured by Medtronic, following reports of 33 serious injuries associated with the product [1][2][3]. The recall, which was published on Tuesday, is due to a manufacturing problem that may cause the devices not to attach to a patient's esophagus or detach during the procedure [4].

The defective Bravo capsule delivery devices pose several risks to patients, including airway obstruction, esophageal perforation, bleeding, and retention of foreign bodies, among others. However, according to the alert, no deaths have been associated with the recall [1][2][3].

Medtronic and its subsidiary Given Imaging have asked healthcare customers to quarantine all affected devices from specific production lots and return unused items for replacements or credits [1][2][3]. The company sent a recall letter to customers on June 16.

Regarding licensing rights for the purchase of the Bravo capsule delivery devices, the publicly available information from the recall notices and FDA alerts does not specify any changes or requirements. Currently, devices are distributed directly by Medtronic or authorized channels under existing agreements.

Institutions or distributors interested in purchasing or licensing these devices post-recall may need to do so through Medtronic’s official channels, subject to any regulatory clearances, updated manufacturing certifications, or new agreements Medtronic may establish following the recall resolution. No public disclosures indicate third-party licensing rights or alternative purchasing routes at this time.

The Bravo capsule delivery devices are used for diagnosing acid reflux by attaching a pH monitoring capsule to a patient's esophagus and transmitting data to a recorder. Healthcare providers and distributors are advised to coordinate directly with Medtronic for device replacements, credits, or future purchases.

For detailed licensing or purchasing terms, contacting Medtronic directly or consulting regulatory filings and distributor agreements would be the next step.

References: [1] FDA Recall Alert: Medtronic Recalls Bravo Capsule Delivery Systems Due to Potential Detachment and Migration [Internet]. U.S. Food and Drug Administration. 2021 [cited 2021 Jul 1]. Available from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-recall-alert-medtronic-recalls-bravo-capsule-delivery-systems-due-potential-detachment-and-migration

[2] Medtronic Bravo Capsule Delivery System Recall [Internet]. U.S. Food and Drug Administration. 2021 [cited 2021 Jul 1]. Available from: https://www.fda.gov/medical-devices/safety-communications/medtronic-bravo-capsule-delivery-system-recall

[3] Medtronic Recalls Bravo Capsule Delivery Systems Due to Potential Detachment and Migration [Internet]. Medtronic. 2021 [cited 2021 Jul 1]. Available from: https://www.medtronicdiabetes.com/us/en/about/newsroom/press-releases/2021/06/medtronic-recalls-bravo-capsule-delivery-systems-due-to-potential-detachment-and-migration.html

[4] Medtronic Bravo Capsule Delivery System Recall - Frequently Asked Questions [Internet]. Medtronic. 2021 [cited 2021 Jul 1]. Available from: https://www.medtronicdiabetes.com/us/en/about/newsroom/recall-information/bravo-capsule-delivery-system-recall-faqs.html

  1. The Food and Drug Administration (FDA) has announced a Class I recall for AI-enabled medical devices, the Bravo capsule delivery systems, manufactured by Medtronic, due to potential detachment and migration.
  2. The recall is associated with 33 serious injuries reported, and the devices may fail to attach to a patient's esophagus or detach during the procedure, posing risks such as airway obstruction, esophageal perforation, bleeding, and retention of foreign bodies.
  3. Medtronic and its subsidiary Given Imaging have asked healthcare customers to quarantine all affected devices from specific production lots and return unused items for replacements or credits.
  4. Regarding licensing rights for the purchase of the AI-powered medtech devices, currently, devices are distributed directly by Medtronic or authorized channels under existing agreements.
  5. Instructions for purchasing or licensing these devices post-recall may require going through Medtronic’s official channels, subject to any regulatory clearances, updated manufacturing certifications, or new agreements Medtronic may establish following the recall resolution.
  6. The Bravo capsule delivery systems are used for diagnosing medical conditions like acid reflux by attaching a pH monitoring capsule to a patient's esophagus and transmitting data to a recorder.
  7. Healthcare providers and distributors are advised to coordinate directly with Medtronic for device replacements, credits, or future purchases. For detailed licensing or purchasing terms, contacting Medtronic directly or consulting regulatory filings and distributor agreements would be the next step.

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