FDA Medical Device Recalls (openFDA)
Micro Therapeutics Inc, Dba Ev3 Neurovascular: ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
- Recall number
- Z-3022-2018
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Product
- ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
- Status
- Terminated
- Initiated
- 2018-08-10
- Posted
- not on file
- Terminated
- 2020-08-04
- Reason
- The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.
- Root cause
- Process control
- Action
- Medtronic began notifying the Consignees on 10-Aug-2018. Consignees were asked to quarantine and return affected product.
- Quantity
- 67 units
- Distribution
- Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
- Lot, serial or model codes
- Lot Number A495368
- 510(k) numbers
- ["K111723"]
- PMA numbers
- not on file
- Product code
- MCW
- Firm FEI
- 3004904811
- Firm city
- Irvine
- Firm state
- CA
- 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