Agency classClass IIOur severity:Severe FDA (Devices)·Z-1133-2017·Announced 2017-02-08

Medtronic Intact Disposable Wands Recalled for Sterility Compromise

Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 275 units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a compromised sterile barrier (which poses a risk of infection) is classified as Severe (Score 4), particularly given the lack of reported hospitalizations which would elevate it to Critical, but the significant risk of harm from non-sterile medical devices.

Plain-English summary

Medtronic Advanced Energy, LLC is recalling Intact Disposable Wands (part of the Intact System), catalog number 900-120. These medical devices 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.

The recall was initiated because the product sterility was compromised due to a breach of the sterile barrier. The recall involves 275 units across all lot codes. The products were distributed worldwide, including in the United States, China, Greece, the Netherlands, Egypt, Turkey, and Switzerland.

Healthcare providers and facilities should stop using these devices and contact Medtronic Advanced Energy, LLC for instructions on return or replacement. Patients who have already received treatment with these devices should contact their healthcare provider with any questions or concerns.

The recalled product

Product: Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm 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…
Manufacturer: Medtronic Advanced Energy, LLC
Category: Medical Device — Surgical Instruments
Hazard: infection
sterility-compromise
Affected units: 275

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lot codes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Medtronic Advanced Energy, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Same manufacturer · Medtronic Advanced Energy, LLC

See all →

High
Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise
FDA (Devices) · 2017-02-08
High
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
Severe
Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise
FDA (Devices) · 2017-02-08
High
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
Severe
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08

Same hazard · infection