Covidien recalls CF Delivery Dev Caps Bravo x5 (FGS-0635/FGS-0636) for risk of capsule aspiration leading to low oxygen, intubation, and hospital stay. 13 reports of aspiration 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 CF Delivery Dev Caps Bravo x5 capsules that may fail to attach to the esophagus, causing the capsule to be aspirated into the lungs. This can lead to serious health issues requiring immediate medical intervention, including intubation and extended hospital stays.
The capsule may not stay properly attached to the esophagus, which can cause it to be inhaled into the lungs. If aspirated, it may lead to low oxygen levels, requiring immediate removal by medical staff and potentially causing intubation or extended hospitalization.
Adults and children aged 4 and older who use these capsules for gastroesophageal pH monitoring are affected. Patients with conditions that increase aspiration risk may be at higher risk.
Check for the model numbers FGS-0635 or FGS-0636 on the packaging. These capsules are used for measuring stomach acid in adults and children 4 years and older.
If the capsule is inhaled into the lungs, seek immediate medical help.
The capsules may fail to attach to the esophagus, leading to aspiration into the lungs, which can cause serious health issues requiring immediate medical intervention.
The recall includes specific model numbers FGS-0635 and FGS-0636, but the exact number of units is not stated in the official notice.
If you have the recalled capsules, check for aspiration symptoms and seek medical help immediately if the capsule is inhaled. There is no specific remedy provided in the recall notice.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1334-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1334-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
