ConcertoTMRecalls & reported problems across all models
Micro Therapeutics, Inc. · 70 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 436
- Deaths reported
- 4
- Injuries reported
- 31
- Recalls
- 0
We found 70 models of ConcertoTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 436 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2017 and Nov 17, 2025 — classified as 4 deaths, 31 injuries, 401 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (215 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ConcertoTM problems
Device problems
- Separation Failure215
- Physical Resistance/Sticking102
- Detachment of Device or Device Component99
- Break39
- Material Deformation28
- Migration20
- Adverse Event Without Identified Device or Use Problem15
- Inadequacy of Device Shape and/or Size7
Patient problems
- No Clinical Signs, Symptoms or Conditions247
- No Known Impact Or Consequence To Patient155
- Device Embedded In Tissue or Plaque8
- Insufficient Information8
- Foreign Body In Patient7
- Aneurysm5
- Embolism/Embolus4
- Pseudoaneurysm4
ConcertoTM models
70 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ConcertoTM NV-2-8-HELIXDevice, Vascular, for Promoting Embolization32 reports
- ConcertoTM NV-2-8-HELIXDevice, Vascular, for Promoting Embolization26 reports
- ConcertoTM NV-3-8-HELIXDevice, Vascular, for Promoting Embolization25 reports
- ConcertoTM NV-2-4-HELIXDevice, Vascular, for Promoting Embolization20 reports
- ConcertoTM NV-2-6-HELIXDevice, Vascular, for Promoting Embolization18 reports
- ConcertoTM PV-20-50-HELIXDevice, Vascular, for Promoting Embolization1 death18 reports
- ConcertoTM NV-5-20-HELIXDevice, Vascular, for Promoting Embolization16 reports
- ConcertoTM NV-2-6-HELIXDevice, Vascular, for Promoting Embolization15 reports
- ConcertoTM NV-3-8-HELIXDevice, Vascular, for Promoting Embolization15 reports
- ConcertoTM PV-12-30-HELIXDevice, Vascular, for Promoting Embolization13 reports
- ConcertoTM NV-8-30-HELIXDevice, Vascular, for Promoting Embolization12 reports
- ConcertoTM PV-18-40-HELIXDevice, Vascular, for Promoting Embolization12 reports
- ConcertoTM NV-2-4-HELIXDevice, Vascular, for Promoting Embolization11 reports
- ConcertoTM NV-6-20-HELIXDevice, Vascular, for Promoting Embolization11 reports
- ConcertoTM NV-7-30-HELIXDevice, Vascular, for Promoting Embolization11 reports
- ConcertoTM PV-2-6-3DDevice, Vascular, for Promoting Embolization9 reports
- ConcertoTM NV-4-10-HELIXDevice, Vascular, for Promoting Embolization2 deaths8 reports
- ConcertoTM NV-8-30-HELIXDevice, Vascular, for Promoting Embolization8 reports
- ConcertoTM NV-6-20-HELIXDevice, Vascular, for Promoting Embolization7 reports
- ConcertoTM NV-3-4-HELIXDevice, Vascular, for Promoting Embolization7 reports
- ConcertoTM NV-4-8-HELIXDevice, Vascular, for Promoting Embolization7 reports
- ConcertoTM NV-5-15-HELIXDevice, Vascular, for Promoting Embolization7 reports
- ConcertoTM NV-4-10-HELIXDevice, Vascular, for Promoting Embolization6 reports
- ConcertoTM PV-3-8-3DDevice, Vascular, for Promoting Embolization6 reports
- ConcertoTM NV-5-15-HELIXDevice, Vascular, for Promoting Embolization5 reports
- ConcertoTM NV-5-20-HELIXDevice, Vascular, for Promoting Embolization5 reports
- ConcertoTM PV-12-30-HELIXDevice, Vascular, for Promoting Embolization5 reports
- ConcertoTM PV-18-40-HELIXDevice, Vascular, for Promoting Embolization5 reports
- ConcertoTM NV-10-30-HELIXDevice, Vascular, for Promoting Embolization5 reports
- ConcertoTM PV-14-30-HELIXDevice, Vascular, for Promoting Embolization5 reports
- ConcertoTM PV-3-6-3DDevice, Vascular, for Promoting Embolization5 reports
- ConcertoTM PV-6-20-3DDevice, Vascular, for Promoting Embolization5 reports
- ConcertoTM NV-7-30-HELIXDevice, Vascular, for Promoting Embolization4 reports
- ConcertoTM PV-16-40-HELIXDevice, Vascular, for Promoting Embolization1 death4 reports
- ConcertoTM PV-3-8-3DDevice, Vascular, for Promoting Embolization4 reports
- ConcertoTM PV-18-40-3DDevice, Vascular, for Promoting Embolization4 reports
- ConcertoTM PV-16-40-HELIXDevice, Vascular, for Promoting Embolization4 reports
- ConcertoTM NV-9-30-HELIXDevice, Vascular, for Promoting Embolization3 reports
- ConcertoTM PV-20-50-HELIXDevice, Vascular, for Promoting Embolization3 reports
- ConcertoTM PV-6-20-3DDevice, Vascular, for Promoting Embolization3 reports
- ConcertoTM PV-2-4-3DDevice, Vascular, for Promoting Embolization3 reports
- ConcertoTM PV-4-12-3DDevice, Vascular, for Promoting Embolization3 reports
- ConcertoTM PV-8-30-3DDevice, Vascular, for Promoting Embolization3 reports
- ConcertoTM PV-18-40-3DDevice, Vascular, for Promoting Embolization3 reports
- ConcertoTM NV-3-4-HELIXDevice, Vascular, for Promoting Embolization2 reports
- ConcertoTM NV-4-8-HELIXDevice, Vascular, for Promoting Embolization2 reports
- ConcertoTM PV-12-40-HELIXDevice, Vascular, for Promoting Embolization2 reports
- ConcertoTM PV-14-30-HELIXDevice, Vascular, for Promoting Embolization2 reports
- ConcertoTM PV-8-30-3DDevice, Vascular, for Promoting Embolization2 reports
- ConcertoTM PV-10-30-3DDevice, Vascular, for Promoting Embolization2 reports
- ConcertoTM PV-5-15-3DDevice, Vascular, for Promoting Embolization2 reports
- ConcertoTM PV-9-30-3DDevice, Vascular, for Promoting Embolization2 reports
- ConcertoTM PV-10-30-3DDevice, Vascular, for Promoting Embolization2 reports
- ConcertoTM NV-10-30-HELIXDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM NV-10-30-HELIXDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-14-30-HELIXDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-14-40-HELIXDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-2-2-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-2-6-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-3-6-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-4-10-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-5-15-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-14-40-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-16-40-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM NV-9-30-HELIXDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-2-2-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-7-30-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-12-40-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-14-40-3DDevice, Vascular, for Promoting Embolization1 report
- ConcertoTM PV-16-40-3DDevice, Vascular, for Promoting Embolization1 report
Recent ConcertoTM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2025Break; Break
MEDTRONIC RECEIVED A REPORT THAT AT THE TIME OF MANUAL RELEASE OF THE COIL, THE BLACK INDICATOR/MARK OF THE INPUT WAS CUT/BROKEN AND THE THREAD OF THE COIL WAS NOT VISIBLE/DID NOT APPEAR TO DISASSEMBLE IT. THE COIL REMAINED INSIDE THE CATHETER WITHOUT DIFFICULTY IN REMOVING THE COIL BUT THE MEDICAL TEAM NO LONGER HAD A WAY TO POSITION OR DEPLOY IT. IT WAS DECIDED TO REMOVE THE ENTIRE WIRE. THE DEVICE HAD BEEN INSPECTED WITH NO ISSUES NOTED. A BREAK WAS REPORTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A DISTAL ARTERY. THE DEGREE OF TORTUOSITY WAS LITTLE. THERE WAS NO DEGREE OF CALCIFICATION AND NO STENOSIS. ARTERY DIAMETER WAS 3-4MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23570371 ↗MalfunctionFeb 4, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT THE CONCERTO COIL DID NOT DETACH WHEN ATTEMPTED. NO PATIENT INFORMATION WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21303214 ↗MalfunctionNov 27, 2024Break; Break
IT WAS REPORTED THAT DURING THE REMOVAL OF THE COIL CONCERTO 3D 5MM X 15CM FROM THE ANTERIOR TIBIAL ARTERY, THE MICROCATHETER COILS BROKE, RESULTING IN THE COILS REMAINING INSIDE THE CATHETER. THE PROCEDURE WAS CONDUCTED ON THE LEFT MID ANTERIOR TIBIAL ARTERY, WHICH HAD A DIAMETER OF 3MM AND A LESION LENGTH OF 40MM. THERE WAS NO TORTUOSITY OR CALCIFICATION NOTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE DEFECTIVE COILS WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800574 ↗MalfunctionNov 14, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THE LESION CHARACTERISTICS WERE IN THE AORTA. THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. THE RESISTANCE WAS IN THE DISTAL END OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. MANUAL DETACHMENT, IT DETACHED WITH ONE ATTEMPT TO REMOVE IT. NO DAMAGE TO THE PUSHWIRE WAS NOTED. THE COIL WAS REMOVED FROM PATIENT AT THE TIME OF SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20686400 ↗MalfunctionSep 30, 2024Separation Failure; Separation Failure
ADDITIONAL INFORMATION RECEIVED REPORTED A FEW ATTEMPTS WERE MADE TO DETACH WITH THE INSTANT DETACHER. NO ATTEMPTS WERE MADE TO DETACH WITH THE MANUAL METHOD. THERE WERE NO ISSUES PRIOR TO COIL NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER IT WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20339074 ↗MalfunctionAug 19, 2024Separation Failure; Separation Failure
ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE DETACHMENT WAS NOT DETERMINED. PRIOR TO NON-DETACHMENT NO ISSUES WERE ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20000302 ↗MalfunctionJul 16, 2024Separation Failure; Separation Failure
MEDTRONIC RECEIVED REPORT THAT TWO CONCERTO COIL COULD NOT BE DETACHED. IT WAS NOTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COILS WERE NOT IMPLANTED AND WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY. ANCILLARY DEVICE: PROGREAT 2.4 MICROCATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19748925 ↗InjuryJun 17, 2024Migration; Physical Resistance/Sticking; Migration; Physical Resistance/Sticking
MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL MIGRATED AND AN ECHELON HAD DIFFICULT NAVIGATION. 1ST DID LEFT SUPERIOR VENA CAV A (SVC) ¿ VERY TORTUOUS USED ECHELON COULDN¿T GET 4FR GUIDE CATH. SO COULDN¿T PUT A PLUG, SO COILED WITH A 3D 6X20. THINKS IT MAY HAVE BEEN OVERSIZED BECAUSE IT DIDN¿T PACK WELL. PROXIMAL TORTUOSITY. GRABBED MICRO AND WAS GOING TO PUT IN A 2ND COIL BUT WHEN MICRO TOUCHED IT THE COIL MOVED DISTALLY, TO A SEGMENT THAT WAS IN A LARGER DIAMETER SEGMENT OF THE VESSEL. THE HEALTHCARE PROVIDER (HCP) WAS CONSIDERING SNARING IT AND GOT A 2ND OPINION. THE COIL APPEARED TO BE IN A STABLE POSITION, SO THEY DIDN¿T SNARE IT. THEN EMBOLIZED VERY PROXIMALLY WITH A 5X15 3D. IT MOVED TO THE RIGHT SIDE. DID THE MVPS AND STENT AND FINISHED THE CASE AND IT REMAINED STABLE. SOMEONE CAME IN AND SWITCHED HIS G TUBE TO A J TUBE AND THEY DID 3 FLUOROS AND THE COIL HADN¿T MOVED. THE G TUBE WAS VERY CLOSE TO THE COIL. NEXT DAY THE COIL WASN¿T WHERE THEY LAST SAW IT. AFTER LOOKING FOR IT, THEY FOUND IT HAD EMBOLIZED TO LEFT INTERNAL CAROTID. TOOK HIM TO NEUROSURGERY. CEREBRAL ANGIO. CRANIOTOMY. DISSECTED TO LEFT MIDDLE CEREBRAL ARTERY. DUEL ANTI PLATELET THERAPY. HAD A STROKE ON
Patient problems: Foreign Body Embolism; Foreign Body In Patient; Ischemia Stroke
MAUDE report 19554920 ↗MalfunctionMay 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO CATHETER HAD ISSUES WITH THE CATHETER. 4 COILS OF THE SAME SIZE WITH THE SAME LOT. DESPITE THE Y CONNECTOR AND IRRIGATION, THE TERUMO PROGREAT 2.4FR MICROCATHETER COULD NOT BE USED, AND A 2.8FR TERUMO MICROCATHETER WAS ALSO UNSUCCESSFUL. THE PATIENT IS ALIVE WITH NO INJURY. NO OTHER INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CONCERTO COILS COULD NOT BE PUSHED OUT, EVENT FLUSHING OR CHANGE TO A BIGGER SIZE PROGREAT 2.8F DID NOT SOLVE THE PROBLEM. THERE WAS NO OBVIOUS DEVICE ISSUE AND NOT PATIENT/THERAPY OR PROCEDURE ISSUE. CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL AFTER REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391401 ↗MalfunctionMay 23, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE, THE CONCERTO COIL WOULD NOT ENTER THE MICRO-CATHETER. IN ANOTHER ATTEMPT, THE DOCTOR WAS ABLE TO ADVANCE THE COIL INTO THE MICRO-CATHETER BUT IT WOULD NOT DETACH/SEPARATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382195 ↗MalfunctionMay 21, 2024Material Deformation; Material Deformation
MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL PUSHWIRE WAS BENT AT THE PROXIMAL END THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED RENAL ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 7 MM, NECK DIAMETER 5 MM. THE PATIENT¿S VESSEL TORTUOSITY AND BLOOD FLOW WAS NORMAL. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE WAS COMPLETED BY USING A ANOTHER CONCERTO COIL. THE WIRE WAS BENT WHEN IT WAS OPENED. THERE WERE ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND, IT WAS STATED THERE WAS AN INFLUENCE OF THE OPERATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19363489 ↗MalfunctionMay 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THREE CONCERTO COILS WOULD NOT ADVANCE IN MICROCATHETER VERY FAR BEFORE GETTING STUCK. ONLY WOULD ADVANCE JUST PAST THE HUB. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE PROXIMAL SECTION OF THE CATHETER. THE COIL (LOT # 227937283) DID PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288229 ↗MalfunctionMay 6, 2024Stretched; Separation Failure; Stretched; Separation Failure
ADDITIONAL INFORMATION WAS RECEIVED. AT LEAST 3 ATTEMPTS WERE MADE TO SEPARATE THE COIL USING THE INSTANT DETACHER. 2 MORE ATTEMPTS WERE MADE TO SEPARATE THE COIL USING THE MANUAL METHOD. PRIOR TO THE NON-REMOVAL OF THE COIL, THERE WERE NO PROBLEM. THE PUSHER WIRE WAS OBSERVED TO BE STRETCHED AFTER REMOVAL FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19256447 ↗MalfunctionMay 3, 2024Separation Failure; Separation Failure
MEDTRONIC RECEIVED A REPORT THAT THERE WAS COIL NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 10 TIMES. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER 5 TIMES. THERE WERE NO MANUAL ATTEMPTS TO DETACH VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED SPLENIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 14MM AND A 8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MODERATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19239421 ↗MalfunctionApr 19, 2024Separation Failure; Separation Failure
ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. AN INSTANT DETACHER WAS NOT USED. THERE WERE 3 ATTEMPTS AT MANUAL DETACHMENT. THERE WERE NO ISSUES PRIOR TO COIL NON DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19142263 ↗
Other Micro Therapeutics, Inc. products
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- AxiumTM139 models · 832 reports · 1 recall
- PIPELINE114 models · 622 reports · 1 recall
- Concerto Detachable Coil System34 models · 595 reports
- Axium Prime Detachable Coil System70 models · 497 reports
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- Axium Detachable Coil System69 models · 288 reports
- Axium PrimeTM66 models · 237 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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