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Medtronic has recalled certain Bravo CF capsule delivery devices used in reflux testing, and lawyers are reviewing injury cases following nearly 200 reports of serious injury.

On September 15, 2026, the FDA classified the recall as Class I, its most serious category, warning that continued use could cause serious injury or death.

The agency said Medtronic reported 184 serious injuries and no deaths associated with the issue as of Aug. 10, 2026.

Doctors attach the Bravo system capsule to the esophagus to measure pH and help diagnose gastroesophageal reflux disease (GERD). Once attached to the esophagus, the capsule sends pH readings to a recorder worn at the patient’s waist.

Lawyers investigating potential injury claims say the device may not work properly, leading to injuries.

“The Bravo CF Capsule is potentially very dangerous,” said Ellen Relkin, a partner at Weitz & Luxenberg and head of the firm’s defective drugs and medical devices division. “These capsules may not attach to the esophagus as intended, or else improperly detach, leading to severe complications.”

Injuries Linked to the Device

A failed Bravo CF Capsule may potentially lead to obstructed airways, hemorrhaging and lacerations. Patients may need surgical removal or repair, and if the removal is not successful, it can cause more serious injuries, according to Relkin.

The FDA lists several risks associated with the recalled devices:

  • Inhaling the capsule into the airway
  • A blocked airway
  • Holes or cuts in the esophagus
  • Bleeding
  • Foreign material remaining in the body
  • A delayed diagnosis

Medtronic also identifies chest pain as a potential complication of the Bravo pH capsule.

Prior to these recalls, some patients had already reported problems with the capsule.

For example, in a voluntary report dated July 18, 2021, a patient reported to the FDA that a Bravo capsule caused intense chest pain when swallowing and made eating difficult.

The report predates both recalls and does not identify a device lot number linking it to either recall. The FDA cautions that adverse event reports alone cannot establish that a device caused an injury or show how often an injury occurs.

What the Bravo Capsule Recalls Cover

The 2026 recall covers devices with product numbers FGS-0635 (five-pack) and FGS-0636 (single-pack). These recalled devices have expiration dates through October 20, 2027.

Medtronic says a problem with the component that controls capsule deployment may prevent the capsule from attaching to the esophagus or from detaching from the delivery device as intended.

An earlier recall in June 2025 for the same product numbers involved misapplied adhesive during manufacturing and was associated with 33 reported serious injuries and no deaths.

The two recalls involve similar capsule failures that may lead to the same injuries but different underlying causes.

The FDA directs health care providers to stop using affected devices and return unused recalled products to Medtronic.

Medtronic Previously Faced Lawsuits for Other Devices

This isn’t the first time Medtronic has faced lawsuits over one of its devices. Its Infuse Bone Graft, used in spinal fusion surgery, became the subject of personal injury claims and allegations that the company promoted unapproved uses and misrepresented safety risks.

In May 2014, Medtronic announced an agreement to pay approximately $22 million to resolve claims from an estimated 950 claimants, without admitting liability.

Medtronic also faced lawsuits over its Sprint Fidelis defibrillator leads, which were recalled in October 2007 due to a risk of fracture. In October 2010, the company announced a $268 million settlement agreement to resolve U.S. lawsuits and claims involving the leads, without admitting liability.

In August 2026, a jury ordered Medtronic to pay $88 million to a man who filed a hernia mesh lawsuit after complications from Covidien mesh.