CF Delivery Dev Caps Bravo x5 — Class II medical device recall Z-1334-2021
Ongoing recall by Covidien Llc, reported 2021-04-07, distributed nationwide. The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsu
| Recall number | Z-1334-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-04-01 |
| Reported by FDA | 2021-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 62,551 |
| Reason classes | device malfunction |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1334-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.