Food, drugs, devices › Micro Therapeutics Inc, Dba Ev3 Neurovascular
Device recall: ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C fo
FDA enforcement event 80831 is a device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular of Irvine, CA, initiated 10 Aug 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 4 Aug 2020. Initiation: voluntary: firm initiated. Micro Therapeutics Inc, Dba Ev3 Neurovascular has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Micro Therapeutics Inc, Dba Ev3 Neurovascular, Irvine, CA.
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."
Distribution
"Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3022-2018 | ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use. | 67 units | Class II | Terminated | 19 Sep 2018 |
Context
Other enforcement events for Micro Therapeutics Inc, Dba Ev3 Neurovascular
All 8 events for Micro Therapeutics Inc, Dba Ev3 Neurovascular
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.