Recall Z-1334-2021 ยท FFT Electrode, Ph, Stomach
Covidien Llc
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
| Date | Feb 26, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process change control |
| Action | On February 26, 2021, the firm initiated mailing of Urgent Medical Device Recall letters to affected customers. Customers were advised that in cases where the capsule fails to attach to the esophageal mucosa, the potential exists for 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 |
| Quantity | 62,551 |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES Given Imaging , Ltd., Dec 1, 2010 |