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Axium Prime Detachable Coil System
Micro Therapeutics, Inc. · Model APB-3-10-HX-ES · UDI-DI 00763000313982
1
510(k) clearances
26,211
Adverse events (640 deaths)
68
Recalls
63
Facilities
Description
COIL APB 3-10 HX-ES V06
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-06 | Stryker Neurovascular | Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be |
| 2025-10-02 | Cerenovus Inc | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. |
| 2025-05-08 | BALT USA, LLC | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
| 2024-01-03 | BALT USA, LLC | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of sold |
| 2022-09-07 | BALT USA, LLC | Product pouch label does not match up with carton label |
| 2022-07-26 | BALT USA, LLC | Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. |
| 2022-04-27 | Micro Therapeutics, Inc. | Due to incorrect size and configuration labeling of the detachable coil system. |
| 2022-01-04 | BALT USA, LLC | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mi |
| 2019-11-22 | Microvention, Inc. | The devices may be missing the implant coil. |
| 2019-11-22 | Microvention, Inc. | The devices may be missing the implant coil. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.