FDA Medical Device Recalls (openFDA)
Medtronic Advanced Energy, LLC: Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm 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.
- Recall number
- Z-1136-2017
- Recalling firm
- Medtronic Advanced Energy, LLC
- Product
- Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm 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.
- Status
- Terminated
- Initiated
- 2016-12-28
- Posted
- 2017-02-02
- Terminated
- 2017-05-11
- Reason
- Product sterility compromised due to breach of sterile barrier
- Root cause
- Package design/selection
- Action
- Medtronic Advanced Energy notified customers by letter on December 27, 2016 via Next Day FEDEX. The communication advises users to immediately stop using the affected Intact Disposable Wands and to quarantine them until they can be returned to Medtronic. Medtronic Sales representatives will arrange for the return of all recalled product.
- Quantity
- 105 units
- Distribution
- Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
- Lot, serial or model codes
- All lot codes
- 510(k) numbers
- ["K003190"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 1000517638
- Firm city
- Portsmouth
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28