Food, drugs, devices › Micro Therapeutics Inc, Dba Ev3 Neurovascular
Device recall: -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices con
Micro Therapeutics Inc, Dba Ev3 Neurovascular (Irvine, CA) initiated this device recall on 4 Sep 2015; FDA lists 1 product record under event 72165, classified Class II.
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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 18 May 2017. 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 firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use."
Distribution
"US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0120-2016 | -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from… | 23 devices | Class II | Terminated | 21 Oct 2015 |
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 firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use."
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: "US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 May 2017. "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.