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Terminated

Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

FDA Recall Z-3054-2017 · Posted None

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodePGW
Date Initiated2017-06-29
Date Terminated2018-08-03
Product Quantity60 instruments

Reason for Recall

The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.

Firm Action

Medtronic sent an Urgent Medical Device Recall letter dated June 25, 2017, via overnight mail on June 29, 2017, to all affected customers. Letters to foreign customers are being handled by geography-specific Regulatory Specialists. Customers were instructed examine their inventory for the affected product and immediately quarantine them for return for Medtronic. Customers with affected product were instructed to contact Medtronic Technical Services at 1-800-595-9709 to receive a return material authorization (RMA) and arrange for their return and no charge replacements. Customers were asked to complete and follow instructions on the attached Consignee Response Form. Sign and date the bottom of the form and then return the form to Medtronic at RS [email protected] or fax it to Medtronic Technical Services at 651-367-7075. Customers with questions were instructed to call 1-800-595-9709.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc. · 2016-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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