Food, drugs, devices › Micro Therapeutics Inc, Dba Ev3 Neurovascular
Device recall: ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA enforcement event 85069 is a device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular of Irvine, CA, initiated 14 Feb 2020 and classified Class I, with 2 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 12 Jun 2024. 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
"Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue."
Distribution
"Worldwide distribution. US nationwide, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1527-2020 | ev3 Pipeline Flex Embolization Device. For neurological endovascular use. | 1050 | Class I | Terminated | 1 Apr 2020 |
| Z-1528-2020 | ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use. | 762 | Class I | Terminated | 1 Apr 2020 |
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: "Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US nationwide, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Jun 2024. "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.