Medical device software defect causes incorrect rotation count in surgical handpiece
Medtronic Xomed integrated power console software version 2.7.3.0 has a defect that causes the set number of rotations to mismatch the actual rotations in specific modes when used with M5 handpieces. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for a risk-of-harm medical device where a functional defect (rotation count mismatch) could affect surgical performance. No injuries have been reported, placing it in the High category per the rubric.
Plain-English summary
Medtronic Xomed, Inc. is recalling certain integrated power console (IPC) systems running software version 2.7.3.0. The affected products include Console 1898001 IPC (Product Number 1898001), Console IPC Refurb (Product Number EC300RF), and Master Console EC300 Legend EHS (Product Number EC300). A total of 1447 units were distributed internationally to Japan.
The software defect causes a mismatch between the set number of rotations and the actual number of rotations in a specific mode when the console is used with Medtronic's M5 handpiece. This functional defect could affect the accuracy and performance of the integrated power console in surgical applications.
No injuries or illnesses related to this defect have been reported. The recall was initiated after the defect was discovered during product evaluation.
Healthcare facilities and users with affected systems should contact Medtronic Xomed immediately for instructions on obtaining a software update or replacement. Affected devices can be identified by product number and specific lot or serial numbers documented in the FDA recall notice.
The recalled product
- Product
- Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- rotation-count-mismatch
- device-malfunction
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 (20)
- a) Product Number 1898001
- GTIN 00613994752246
- Lot Serial Numbers: 72158
- 72162
- 72167
- 72178
- 72176
- 72205
- 72206
- 72208
- 72234
- 72323
- 72315
- 72326
- 72339
- 72340
- 72342
- 72372
- 72404
- 72419
Distribution
Distribution scope not specified by the agency.
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