Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Intact Disposable Wands (part of the Intact System) 777-110: 5 Recalled by Medtronic Advanced Energy, LLC Due to Product sterility compromised due to breach of sterile...

Date: December 28, 2016
Company: Medtronic Advanced Energy, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Advanced Energy, LLC directly.

Affected Products

Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Quantity: 10 units

Why Was This Recalled?

Product sterility compromised due to breach of sterile barrier

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Advanced Energy, LLC

Medtronic Advanced Energy, LLC has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report