Food, drugs, devices › Micro Therapeutics, Inc.
Device recall: AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Micro Therapeutics, Inc. (Irvine, CA) initiated this device recall on 27 Apr 2022; FDA lists 1 product record under event 90178, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Micro Therapeutics, Inc. has 6 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Micro Therapeutics, Inc., Irvine, CA.
Reason for recall
"Due to incorrect size and configuration labeling of the detachable coil system."
Distribution
"International distribution in the countries of China and Republic of Korea."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1261-2022 | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D; | 96 systems | Class II | Ongoing | 22 Jun 2022 |
Context
Other enforcement events for Micro Therapeutics, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Jun 2026 | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flo | Device | Class II | 2 |
| 30 Jan 2025 | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-3 | Device | Class I | 2 |
| 11 Jan 2024 | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf | Device | Class II | 2 |
| 30 Jun 2022 | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only | Device | Class II | 2 |
| 13 Jul 2021 | Pipeline Flex Embolization Device | Device | Class I | 2 |
All 6 events for Micro Therapeutics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to incorrect size and configuration labeling of the detachable coil system."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "International distribution in the countries of China and Republic of Korea."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.