Z-3022-2018Class II

ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model...

Name: Z-3022-2018 ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model...
Creator: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Published: 2018-08-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-08-10 / Terminated / root cause: manufacturing process

FDA source

Micro Therapeutics Inc, Dba Ev3 Neurovascular began a recall of ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use on 2018-08-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3022-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-10
Posted: 2018-09-11
Terminated: 2020-08-04
Recalling firm: Medtronic, Inc.
Product: ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Product code: MCW Catheter, Peripheral, Atherectomy
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic began notifying the Consignees on 10-Aug-2018. Consignees were asked to quarantine and return affected product.
Quantity in commerce: 67 units
Distribution: Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
Product codes and lots: Lot Number A495368

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3022-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3022-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-11

Product code MCW

K111723Class IITurbohawk Peripheral Plaque Excision SystemEv3, Inc. / cleared 2011-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)