A gastroenterologist threads a catheter down a patient’s esophagus, presses a small capsule against the wall, and lets go. Two things then have to happen. The capsule stays. The catheter comes out without it.
On August 27 the FDA issued an early alert saying that with Medtronic’s Bravo CF delivery device, sometimes neither one happens. The capsule fails to attach, or it fails to release. As of August 10, Medtronic had reported 184 serious injuries and no deaths. The risks the FDA lists include perforation of the esophagus, obstruction of the airway, hemorrhage, and foreign bodies remaining in the patient.
Medtronic recalled the same product numbers for the same failure in June 2025. The FDA’s notice this week says the underlying cause is a different one.
Two recalls, one failure, some of the same lots
The 2025 recall letter went out on June 3, with an update on June 16. Medtronic told customers the capsule might not attach or detach because adhesive had been misapplied during manufacturing. Thirty-three serious injuries, no deaths. The FDA classified it a Class I recall in January of this year, its most serious category, meaning continued use could cause serious injury or death.
The 2026 letter went to customers on August 6. This time Medtronic traced the failure to the component that controls deployment of the capsule. Same product numbers, FGS-0635 and FGS-0636. Same failure, described to the same customers. And according to the FDA, a subset of the lots covered now had already been covered by the June 2025 notification, which means some of these boxes came off a shelf twice for two different reasons.
The list of risks is the same in both notices, in the same order, down to the wording: aspiration, perforation of the esophagus, obstruction of the airway, hemorrhage, laceration, delay in diagnosis, foreign bodies remaining in the patient. The injury count went from 33 to 184.
A closed corrective action is not a closed hazard
From inside a quality system the sequence is orderly. Complaints arrive. You investigate, trace the failure to a cause, fix the cause, and verify the fix. Verification asks a narrow question: is the defect gone? Devices built after the change do not show it. The corrective action closes.
The question verification does not ask is whether the harm stopped. Those two come apart whenever a single hazardous situation has more than one route into it. A capsule that will not release from its catheter is the hazardous situation. Adhesive was one road there. The deployment component was another. Close out the first road and the hazard is still standing, and the only place it shows up is the complaint file, where it reads as a new problem instead of the same one.
That one sentence from the FDA, same failure and a different cause, is the most useful thing in the notice, and it is the sentence I would carry back to my own complaint data.
An instruction is the weakest control you can write
The notice adds a detail worth sitting with. Medtronic said the deployment problem can be made worse when the delivery device is not kept straight, as the User Guide instructs.
Medtronic is probably right about that. It is also the weakest kind of risk control available. Design the hazard out, add a protective measure, or write it down for the user, and the order matters because it tracks how much of the work you are handing to somebody else. Information for safety sits last on that list for a reason. The person receiving the instruction is holding a catheter in a patient’s throat, watching a screen, and doing this procedure a handful of times a week.
If your control depends on a clinician executing your written instructions correctly during a procedure, the risk moved onto them, and you wrote down where it went. That is a defensible thing to do when nothing else is available. It is a bad thing to mistake for a fix.
The risk standards work. Compare device injuries over the past decade to what the seventies and eighties looked like and it is remarkable how safe these complicated machines have become, and that is not an accident. But a standard only earns that record when you ask your own data the right question, and the right question is not whether you found something to fix, it is whether the injuries stopped.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for product companies. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →