The Recall Desk

FDA (Devices) recall action 86001

Covidien Llc recalled 2 products on 2020-08-12

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
2020-08-12
Critical
0
Units
644

Why these products were recalled

This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.

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)··2020-08-12

    Beacon EUS Access System Needle Recalled Due to Cannula Detachment

    Covidien is voluntarily recalling 375 units of the Beacon EUS Access System Preloaded Access 90-degree Needle because the cannula may detach during procedures.

    Product
    Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidew
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-08-12

    Beacon EUS Access System Needle Recalled Due to Cannula Detachment

    Covidien is voluntarily recalling 269 Beacon EUS Access System needles because the cannula detached during procedures in three reported cases.

    Product
    Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guide
    Category
    Distribution
    0 states