W&L Taking Cases for Medtronic Bravo CF Capsule Recall Injuries

Weitz & Luxenberg is accepting legal cases from people who suffered injuries due to Medtronic’s defective Bravo CF Capsule. The Center for Devices and Radiological Health branch of the U.S. Food & Drug Administration (FDA) issued an Early Alert. Medtronic and its subsidiary, Given Imaging, Inc., have issued a recall. ⁽¹⁾ This device is used to diagnose reflux disease.

The FDA is alerting the public because this medical device poses a “potentially high-risk” issue. In its Medtronic Bravo Recall, the manufacturer sent a letter to customers recommending that they remove the Bravo CF Capsule from wherever they are sold or being used. ⁽²⁾

“The Bravo CF Capsule is potentially very dangerous. These capsules may not attach to the esophagus as intended, or else improperly detach, leading to severe complications. Device failure can potentially obstruct your airways, and cause hemorrhage and lacerations. This can lead to surgical removal or repair and potentially worse consequences if the removal is not successful,” says Ellen Relkin, a W&L partner and head of our defective drugs and medical devices team.

Recalled Bravo CF Capsules

The Bravo capsule is a diagnostic tool placed in a patient’s esophagus to measure the local pH levels. Medtronic has recalled two batches of the device. These include: ⁽³⁾

• Bravo CF, capsule delivery devices, 5 pack; product number: FGS-0635; UDI-DI: 07290101369707
• Bravo CF, capsule delivery device, 1 pack; product number: FGS-0636; UDI-DI: 07290101369714

Reflux Device Is Defective

On August 6, Medtronic recalled specific batches of its Bravo CF capsule because of their potential to fail. These devices are intended to monitor pH, or stomach acid, levels in your esophagus. ⁽⁴⁾

Medtronic’s Bravo system is designed to “place and attach” a capsule to the mucosal wall of your esophagus. The doctor inserts the device during an endoscopic procedure. The capsule is wireless and should remain in place for several days. Once attached, it both records data and transmits that information to a recorder you wear at your waist. ^{(5) (6)}

You can also interact with the recorder to share your symptoms. The data help doctors diagnose gastroesophageal reflux. The capsule itself is supposed to detach naturally and pass through your digestive tract. ^{(7) (8)}

The main concern with the device is that the capsule may not attach to your esophagus, or it may detach unexpectedly. These are device failures. ⁽⁹⁾

Patients Are Suffering Severe Harm Due to Bravo CF Capsules

At least 184 patients have suffered serious injuries. The company reports that the component of the device controlling the deployment of its capsule may be to blame. In a June 2025 Medtronic Bravo CF recall listed by the FDA, Medtronic recalled a subset of Bravo CF lots for similar problems, but different defects. ⁽¹⁰⁾

W&L Helping People Harmed by Bravo CF Capsules

W&L is planning to file Bravo Capsule lawsuits. We are committed to helping people who were harmed by Bravo CF capsules. If you received one of these devices during an endoscopic procedures, we encourage you to contact us. We can help you consider your legal options:

• Were you told by your doctor or hospital that you received the device and it failed?
• Did you receive medical treatment for an injury due to aspiration and/or inhalation of the Bravo capsule or parts of the device?

Did you suffer any one of these injuries due to a failed Bravo CF capsule?:

• Perforation of your esophagus.
• Laceration of your esophagus.
• Obstruction of your airway.
• Hemorrhage/blood loss/bleeding.
• Foreign bodies remaining in your body.
• A delayed diagnosis of clinical gastroesophageal reflux.
• Subsequent surgery to retrieve a failed Bravo CF capsule or its residue, or repair any injury from the device’s failure.

If so, our defective medical device attorneys can help you explore possible financial compensation. We offer a free initial consultation.

Weitz & Luxenberg is a nationally recognized law firm with a solid history of winning for our clients. We have roughly 40 years of experience in leading complex litigation.

We encourage you to contact us by phone at (917) LAWYERS or by filling out the form on this page. One of our representatives is prepared to take your call. We can begin the process of helping you explore your legal options.