Covidien recalls BRAVO pH capsules for potential aspiration risk. Aspiration may cause low oxygen, hospitalization, or delayed treatment. 13 reports in 2 years.
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.
Covidien is recalling specific BRAVO pH capsules that may fail to attach to the esophagus, risking aspiration. If the capsule is swallowed, it could cause low oxygen, hospitalization, or delayed treatment. This recall follows 13 reported cases of aspiration in the past two years.
The capsule may not stay attached to the esophagus, leading to it being swallowed. If swallowed, it can cause low oxygen levels, require hospital intervention, and delay critical treatment.
Adults and children 4 years and older who use the BRAVO pH capsule for gastroesophageal pH monitoring are affected. Patients with gastric reflux symptoms are at higher risk.
Check for the model numbers FGS-0312 or FGS-0313 on the BRAVO pH capsule packaging. These capsules were sold for gastroesophageal pH measurement in adults and children 4 years and older.
Look for model numbers FGS-0312 or FGS-0313 on the packaging.
Reach out to Covidien for guidance on next steps if you have the recalled model.
The capsule may fail to attach to the esophagus, leading to aspiration. This can cause low oxygen, hospitalization, or delayed treatment, with 13 reported cases in the last two years.
Check the model number on the packaging. If it's FGS-0312 or FGS-0313, contact Covidien for guidance.
Yes, the recall applies to children 4 years and older who use the capsule for gastroesophageal pH monitoring.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1335-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1335-2021 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
