Medtronic Xomed, Inc. Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.
Brand
Medtronic Xomed, Inc.
Lot Codes / Batch Numbers
Model: 1898072 Affected Lot Numbers: 0217355465, 0218377490, 0218687535, 0218928638, 0219310085, 0219639840, 0217856852, 0218472653, 0218714701, 0218958034, 0219443322, 0219639842, 0217858947, 0218472654, 0218721203, 0218958035, 0219448447, 0219639844, 0217859045, 0218665536, 0218745073, 0219004569, 0219465587, 0218203285, 0218666231, 0218746389, 0219201122, 0219518520, 0218263964, 0218666243, 0218864105, 0219255151, 0219550550, 0218293282, 0218687534, 0218900337, 0219281168, 0219619754.
Products Sold
Model: 1898072 Affected Lot Numbers: 0217355465, 0218377490, 0218687535, 0218928638, 0219310085,0219639840, 0217856852, 0218472653, 0218714701, 0218958034, 0219443322,0219639842, 0217858947,0218472654, 0218721203, 0218958035, 0219448447, 0219639844, 0217859045,0218665536, 0218745073, 0219004569,0219465587, 0218203285, 0218666231, 0218746389,0219201122,0219518520,0218263964, 0218666243, 0218864105, 0219255151, 0219550550, 0218293282, 0218687534, 0218900337,0219281168, 0219619754.
Medtronic Xomed, Inc. is recalling Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision due to During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotati. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.
Recommended Action
Per FDA guidance
On June 12th 2020 the firm send a notification to its consignees giving then the following instructions: Actions Required: 1. Immediately locate, quarantine, and return any software cards for Software 1898072 IPC Upgrade v2.7.3.0. Instructions for return are found on the Consignee Confirmation form. 2. Check the software version currently installed on your IPC Console and complete the Customer Confirmation Form. If your IPC has software v2.7.3.0 installed, do not use this console with M5 handpiece. Please record your console serial number and the software version currently loaded. 3. Return the completed Customer Confirmation Form via email to rs.entfca@medtronic.com or regular mail to: Medtronic-Xomed 6743 Southpoint Drive N Jacksonville, FL 32216 ATTN: Mike Tomberlin FCA Coordinator 4. Contact your Medtronic Field Representative to install replacement software Version 2.7.4.0 (CFN 1898073).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026