Recall Z-1528-2020— Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class I · Terminated
Class I FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2020-02-14, terminated 2024-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.. Reason: 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..
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-02-14
- Terminated
- 2024-06-12
- Firm location
- Irvine, CA, United States
Product description
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.