The Recall Desk

FDA (Devices) recall action 87396

Covidien Llc recalled 2 products on 2021-04-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-04-07
Critical
0
Units
125,102

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2021-04-07

    FDA Recalls Bravo pH Capsule Delivery Devices Due to Aspiration Risk

    The FDA is recalling Bravo pH Capsule Delivery Devices because the capsule may fail to attach to the esophagus, leading to aspiration and potential hospitalization.

    Product
    BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-04-07

    CF Delivery Dev Caps Bravo x5 Recalled for Aspiration Risk

    FDA recalls CF Delivery Dev Caps Bravo x5 capsules because they may fail to attach to the esophagus, leading to aspiration.

    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.
    Category
    Distribution
    0 states