Irvine, CA, United States
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls
3 recalls recorded since 2018, most recently on 14 February 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)2
Terminated Class I Medical devices
- Recall started
- 14 February 2020
- Terminated
- 12 June 2024
- 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.
- 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, Nor
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1527-2020, Z-1528-2020
- ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
- ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
Terminated Class II Medical devices
- Recall started
- 10 August 2018
- Terminated
- 4 August 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Terminated Class I Medical devices
- Recall started
- 26 February 2018
- Terminated
- 30 September 2021
- Reason
- There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1701-2018
- MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Inten
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.