Medtronic Curved Suction 70 9733450 EM 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
This recall has been terminated (originally issued June 29, 2017).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- June 29, 2017
- Terminated
- August 3, 2018
- Recall Number
- Z-3052-2017
- Quantity
- 149 instruments
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
Reason for Recall
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Canada.
Lot / Code Info
Lot numbers 17030722, 17022421,17022020, 17020619, 17011918, 17012417, I 17010602, 16122724,16122239, 16122038, 16120563, and 16112362
Root Cause
Device Design
Action Taken
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 NavFCA@medtronic.com or fax it to Medtronic Technical Services at 651-367-7075. Customers with questions were instructed to call 1-800-595-9709.