ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE — Class II medical device recall Z-3022-2018
Terminated recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, reported 2018-09-19, distributed in AZ, CA, FL, GA, KS, KY, LA, MI…. The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the Turb
| Recall number | Z-3022-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular, Irvine, CA, United States |
| Recall initiated | 2018-08-10 |
| Classified | 2018-09-11 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2020-08-04 |
| Distributed | AZ, CA, FL, GA, KS, KY, LA, MI, NE, TX |
| Countries outside the US | CN |
| Quantity | 67 units |
| Lot numbers | A495368 |
Product
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3022-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.