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Class IRecall Confirmed

FDA Classifies Medtronic Bravo CF Capsule Delivery Device Recall as Class I

FDA has classified the recall of specified Medtronic Bravo CF capsule delivery devices as Class I after a deployment-control problem was linked to failures of the capsule to attach to the esophagus or detach from the delivery device as intended.

Type
Recall Brief
Published

Decision support

Decision summary

Official recall information is separated from MedTech Current editorial analysis.

Official recall information

What happened

Medtronic and its subsidiary Given Imaging are removing specified Bravo CF capsule delivery devices after identifying a problem with the component that controls deployment of the pH-monitoring capsule. The capsule may fail to attach to the patient’s esophagus or may fail to detach from the delivery device as intended. FDA classified the recall as Class I on September 15, 2026. As of August 10, 2026, Medtronic had reported 184 serious injuries and no deaths associated with the issue.

MedTech Current analysis

Why it matters

The FDA communication identifies potential aspiration or inhalation, esophageal perforation or laceration, airway obstruction, hemorrhage or blood loss, delayed diagnosis, and a retained foreign body. Organizations should verify lot and expiration-date scope before use. The FDA also notes that some affected lots were included in a June 2025 recall involving the same failure type but a different underlying cause.

Official recall information

Official actions

  • Immediately identify and quarantine all unused affected devices.
  • Return all unused affected products to Medtronic for replacement.
  • Pass the recall information to personnel who need to be aware and to any organization to which affected product was transferred or distributed.
  • Do not return lots with an expiration date of December 10, 2027, or later; those lots are outside the scope of this recall.

Detailed recall information

Detailed sourced information from the published Recall Brief follows.

What changed

Medtronic and its subsidiary Given Imaging are removing specified Bravo CF capsule delivery devices after identifying a problem with the component that controls deployment of the pH-monitoring capsule. The capsule may fail to attach to the patient’s esophagus or may fail to detach from the delivery device as intended. The FDA classified the recall as Class I on September 15, 2026.

The FDA first issued an Early Alert on August 27. According to the FDA communication, the potential consequences include aspiration or inhalation, esophageal perforation or laceration, airway obstruction, hemorrhage or blood loss, delayed diagnosis, and a foreign body remaining in the patient. Medtronic had reported 184 serious injuries and no deaths associated with this issue as of August 10, 2026.

The FDA notes that some affected lots were also included in a June 2025 recall involving the same type of failure but a different underlying cause. The Bravo system is designed to attach a pH-monitoring capsule to the esophagus so it can record pH data and transmit those data to a recorder used to support diagnosis of gastroesophageal reflux.

Who and what are affected

The recall covers Bravo CF capsule delivery devices in 5-packs and 1-packs, product numbers FGS-0635 and FGS-0636, with the UDI-DIs listed above. Affected lot numbers have expiration dates prior to and including October 20, 2027. The FDA recall database identifies Given Imaging Ltd. as the recalling firm and lists recall number Z-3090-2026. It reports 127,416 devices in commerce with worldwide distribution, including nationwide U.S. distribution and Puerto Rico.

What affected organizations should do

According to Medtronic’s recall communication:

  • Immediately identify and quarantine all unused affected devices.
  • Return all unused affected products to Medtronic for replacement.
  • Pass the recall information to personnel who need to be aware and to any organization to which affected product was transferred or distributed.
  • Do not return lots with an expiration date of December 10, 2027, or later, because those lots are outside the scope of this recall.