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Axium™ Detachable Coil System
Micro Therapeutics, Inc. · Model PC-2-4-HELIX · UDI-DI 00763000846282
1
510(k) clearances
14,423
Adverse events (239 deaths)
19
Recalls
102
Facilities
Description
COIL PC-2-4-HELIX V14
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-29 | MICROVENTION INC. | Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targete |
| 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. |
| 2025-04-17 | Cook Incorporated | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil. |
| 2024-02-20 | Boston Scientific Corporation | An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. T |
| 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 |
| 2023-08-24 | MICROVENTION INC. | Peripheral coil system detachable has a potential of unsealed pouch packaging. |
| 2022-05-05 | Cook Incorporated | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2022-05-05 | Cook Incorporated | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2022-05-05 | Cook Incorporated | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2019-11-24 | 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.