Axium™ Prime Detachable Coil System APB-3-6-3D-ESRecalls & reported problems
Micro Therapeutics, Inc. · COIL APB-3-6-3D-ES V14 · Class 2 · Implant
All models of Axium Prime Detachable Coil System (70)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000846923), received between Mar 18, 2025 and Mar 18, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Air Embolism1
- Dysphasia1
- Nervous System Injury1
- Paralysis1
- Reduced Blood Flow1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2024 (MONDAY), TREATMENT WAS PERFORMED FOR AN UNRUPTURED ANEURYSM WITH AN IC OF 6-7 MM. PREOPERATIVE PLAN WAS AFTER PLACING 2 COILS WITH BALLOON ASSIST, THE MICROCATHETER WILL BE REPLACED AND THE PIPELINE WILL BE PLACED. THE RIST WAS SUCCESSFULLY GUIDED SMOOTHLY TO THE VICINITY OF THE CAVERNOUS AREA. AN ATTEMPT WAS MADE ABOUT 3 TIMES TO ACCESS THE ANEURYSM, AND THE MICROCATHETER WAS SUCCESSFULLY PLACED IN THE ANEURYSM. ONE APB-3-8-3D AND ONE APB-3-6-3D WERE PLACED WITH BALLOON ASSIST. UPON PERFORMING A CONTRAST IMAGING USING THE RIST, DECREASED PERIPHERAL BLOOD FLOW WAS FOUND (PERIPHERAL FROM M3). HEALTHCARE PROVIDER (HCP) COMMENTED THAT THERE WAS A POSSIBILITY THAT A THROMBUS MIGHT HAVE RELEASED WHEN INDUCED TO AN ANEURYSM USING THE MICROCATHETER. PIPELINE PLACEMENT WAS DISCONTINUED AT THE DISCRETION OF THE HCP. RE-TREATMENT IS SCHEDULED AT A LATER DATE AFTER RECOVERY OF BLOOD FLOW. 2 APB-2-3-3D WERE ADDED, AND THE PROCEDURE WAS COMPLETED. ON MARCH 10 (MONDAY), IT WAS REPORTED THAT A PATIENT IN 40S DEVELOPED A HIGH-LEVEL FUNCTIONAL DISORDER. DETAILS ARE UNKNOWN, BUT THE SYMPTOMS ARE SPEECH IMPAIRMENT AND LOWER HALF OF THE BODY PARALYSIS.
Patient problems: Air Embolism; Dysphasia; Nervous System Injury; Paralysis; Reduced Blood Flow
MAUDE report 21634673 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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