Irvine, CA, United States
Micro Therapeutics, Inc. recalls
7 recalls recorded since 2018, most recently on 25 June 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)7
Terminated or completed0
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 25 June 2026
- Reason
- Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.
- Distribution
- U.S. Nationwide distribution in the states of GA and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3326-2026
- Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewi
Ongoing Class II Medical devices
- Recall started
- 8 June 2026
- Reason
- Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
- Distribution
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2774-2026, Z-2773-2026
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
Ongoing Class I Medical devices
- Recall started
- 30 January 2025
- Reason
- Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
- Distribution
- Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And OUS (foreign) countries of: Algeria, Argentina, Armenia, Austra
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1246-2025, Z-1245-2025
- Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021
- Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027
Ongoing Class II Medical devices
- Recall started
- 11 January 2024
- Reason
- European version of microcatheter were distributed within US which contain a different "Indications for Use".
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, MA, MD, MI, MO, NC, ND, NE, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1253-2024, Z-1252-2024
- The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a hi
- The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a hi
Ongoing Class II Medical devices
- Recall started
- 30 June 2022
- Reason
- Outer carton packaging of microcatheters were exposed to wet substance during transport.
- Distribution
- US Nationwide Distribution: None OUS: Brazil
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1556-2022, Z-1557-2022
- Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
- Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
Ongoing Class II Medical devices
- Recall started
- 27 April 2022
- Reason
- Due to incorrect size and configuration labeling of the detachable coil system.
- Distribution
- International distribution in the countries of China and Republic of Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1261-2022
- AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Ongoing Class I Medical devices
- Recall started
- 13 July 2021
- Reason
- Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV O.U.S.: Argentina, Brazil Canada, Chile, Colombia, Ecuador, Mexico, Peru, Austria,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2403-2021, Z-2402-2021
- EV3 Pipeline Flex Embolization Device with Flex Shield Technology
- Pipeline Flex Embolization Device
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.