FDA Medical Device Recalls (openFDA)
Iotamotion Inc: iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
- Recall number
- Z-0288-2025
- Recalling firm
- Iotamotion Inc
- Product
- iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
- Status
- Completed
- Initiated
- 2024-09-12
- Posted
- 2024-11-01
- Terminated
- not on file
- Reason
- Incorrect GTIN number.
- Root cause
- Process control
- Action
- The firm did not issue any communication. They distributed the devices and saw through their ERP system that the devices had been used. The remainder of the devices were in the possession of the firm's VP, therefore, not viewed as "distributed."
- Quantity
- 5 devices
- Distribution
- Distribution was made to Iowa. There was no government/military/foreign distribution.
- Lot, serial or model codes
- Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QQH
- Firm FEI
- 3030411493
- Firm city
- Vadnais Heights
- Firm state
- MN
- 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