Micro Therapeutics, Inc.
Micro Therapeutics, Inc. holds FDA 510(k) medical device clearances, first cleared 1994, most recent 2012, with 11 FDA device recalls on record.
Top product codes for Micro Therapeutics, Inc.
FDA recalls by Micro Therapeutics, Inc.
10 most recent of 11- Z-2774-2026 — Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
- Z-2773-2026 — Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
- Z-1245-2025 — 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, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50
- Z-1246-2025 — 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, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
- Z-1253-2024 — 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 highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.
- 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 highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.
- Z-1556-2022 — Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
- Z-1557-2022 — Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
- Z-1261-2022 — AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
- Z-2402-2021 — Pipeline Flex Embolization Device
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Micro Therapeutics, Inc.
- K113289 — ORION MICRO CATHETER
- K113454 — 14 WIRE STANDARD, 14 WIRE LS
- K090870 — ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY
- K090046 — CONCERTO DETACHABLE COIL SYSTEM
- K081465 — AXIUM DETACHABLE COIL SYSTEM
- K060747 — FX DETACHABLE COIL SYSTEM
- K060625 — NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
- K051990 — ECHELON MICRO CATHETER
- K051560 — NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
- K051425 — NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
- K050543 — NEXUS DETACHABLE COIL SYSTEM
- K042187 — ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
- K041649 — SAPPHIRE NXT DETACHABLE COIL SYSTEM
- K040694 — MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
- K034036 — MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
- K033372 — SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
- K032497 — SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
- K031852 — SAPPHIRE DETACHABLE FIBER COILS
- K031992 — ECHELON MICRO CATHETER, MODEL 105-5091
- K030392 — SAPPHIRE DETACHABLE COIL SYSTEM
- K030688 — ECHELON MICRO CATHETER, MODEL 105-5092-150
- K024122 — NAUTICA MICRO CATHETER, MODEL 105-5094-153
- K024118 — ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
- K022003 — TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305
- K021066 — MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
- K021139 — TRULINE REINFORCED VALVED INFUSION CATHETER
- K011937 — TRULINE INFUSION CATHETERS
- K011535 — CADENCE PRECISION INJECTOR, MODEL 103-0304
- K011656 — HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
- K011526 — HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
- K010162 — EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
- K010497 — SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
- K010004 — FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
- K002723 — REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA
- K002212 — MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
- K001966 — REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
- K001454 — SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
- K001237 — EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
- K993672 — REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
- K993257 — .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
- K990487 — EQUINOX OCCLUSION BALLOON SYSTEM
- K991225 — MTI 1 ML SYRINGE
- K982543 — SILVERSTREAK HYDROPHILIC GUIDEWIRE
- K974473 — EASY RIDER MICRO CATHETER
- K980104 — FLOW RIDER FLOW DIRECTED MICRO CATHETER
- K973669 — THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
- K963925 — THROMBOLYTIC BRUSH CATHETER
- K964868 — 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER
- K953335 — MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
- K954020 — MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE
- K940634 — MICRO THERAPEUTICS INFUSION CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.