Micro Therapeutics Inc, Dba Ev3 Neurovascular Recall: ev3 Pipeline Flex Embolization Devic
Micro Therapeutics Inc, Dba Ev3 Neurovascular Recall: ev3 Pipeline Flex Embolization Devic is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Micro Therapeutics Inc, Dba Ev3 Neurovascular; Product: ev3 Pipeline Flex Embolization Device. For neurological endovascular use.; Reason for recal
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
|---|---|
| Product | ev3 Pipeline Flex Embolization Device. For neurological endovascular use. |
| 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Worldwide distribution. US nationwide, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Kazakhstan, Korea, Lebanon, Mexico, Netherlands, Norwa |
| Recall initiated | 20200214 |
| Recall number | Z-1527-2020 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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