MicroPlex Helical SoftRecalls & reported problems across all models

We found 9 models of MicroPlex Helical Soft by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2015 and Jan 16, 2020 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

MicroPlex Helical Soft recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 29, 2025Class IIOpen, Classified

   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-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.

   Z-2188-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported MicroPlex Helical Soft problems

MicroPlex Helical Soft models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MicroPlex Helical Soft 100404HC-S-V

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 recall0 reports
• MicroPlex Helical Soft 100208HC-S-V

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• MicroPlex Helical Soft 100310HC-S-V

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• MicroPlex Helical Soft 100410HC-S-V

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• MicroPlex Helical Soft 100308HCSR-S-V

  Device, Vascular, for Promoting Embolization
  1 report
• MicroPlex Helical Soft 100408HCSR-S-V

  Device, Vascular, for Promoting Embolization
  1 report
• MicroPlex Helical Soft 180208HC-S-V

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• MicroPlex Helical Soft 100304HC-S-V

  Device, Vascular, for Promoting Embolization
  1 report
• MicroPlex Helical Soft 100310HC-S-V

  Device, Vascular, for Promoting Embolization
  1 report

Recent MicroPlex Helical Soft adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2020Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION IMPLANT COIL UNEXPECTEDLY DETACHED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT'S OUTCOME IS CURRENTLY REPORTED TO BE "GREAT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9599360 ↗
• MalfunctionNov 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SOMETIME DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT IS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8044865 ↗
• MalfunctionJul 11, 2018Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL STRETCHED DURING REMODELING WITH A BALLOON. THE COIL DETACHED INSIDE THE MICROCATHETER. BOTH SEGMENTS WERE REMOVED IN THEIR ENTIRETY FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677789 ↗
• MalfunctionAug 22, 2016Break; Device Issue; Detachment of Device or Device Component; Break; Device Issue; Detachment of Device or Device Component

  IT WAS REPORTED FROM (B)(6) THAT DURING THE TREATMENT OF AN ANEURYSM AT THE VERTEBRAL ARTERY, UPON ADVANCEMENT OF THE COIL, RESISTANCE WAS ENCOUNTERED. AS THE DEVICE WAS WITHDRAWN, THE DELIVERY PUSHER WAS REPORTED TO BREAK. THE COIL WAS REMOVED WITH THE CATHETER WITHOUT INCIDENT. ADDITIONAL COILS WERE DEPLOYED SUCCESSFULLY. NO INTERVENTION WAS TAKEN. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: Aneurysm

  MAUDE report 5895107 ↗
• MalfunctionAug 2, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue

  IT WAS REPORTED FROM (B)(6) THAT DURING THE EMBOLIZATION TREATMENT OF AN ANEURYSM, THE COIL DID NOT DETACH. UPON WITHDRAWAL, THE COIL DETACHED WITHIN THE MICROCATHETER. THE SYSTEM WAS REMOVED WITHOUT INCIDENT. NO HARM OR INJURY WAS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5841577 ↗
• InjuryJul 12, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue

  IT WAS REPORTED FROM (B)(6) THAT DURING THE COIL EMBOLIZATION TREATMENT OF A LMCA (LEFT MAIN CORONARY ARTERY), THE LAST COIL WAS POSITIONED WITHIN THE ANEURYSM SAC. UPON DEPLOYMENT, THE COIL FAILED TO DETACH. AN ATTEMPT WAS MADE TO REMOVE THE COIL HOWEVER, THIS WAS UNSUCCESSFUL DUE TO THE COIL MASS. MULTIPLE DETACHMENT ATTEMPTS WERE MADE USING THE V-GRIP CONTROLLERS. ON THE 11TH ATTEMPT, THE COIL DETACHED, HOWEVER ANEURYSM PERFORATION OCCURED CAUSING BLEEDING. REMEDIAL ACTION TAKEN: PHARMACEUTICAL COMA WITH FULL MONITORING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 5787699 ↗
• MalfunctionJun 14, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue

  IT WAS REPORTED FROM (B)(6) THAT DURING AN EMBOLIZATION TREATMENT OF AN ANEURYSM, THE COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE ENTIRE SYSTEM WAS REMOVED. NO INTERVENTION WAS TAKEN. NO HARM OR INJURY WAS INCURRED DUE TO THIS INCIDENT.

  Patient problems: Aneurysm

  MAUDE report 5723626 ↗
• MalfunctionMar 31, 2015Stretched; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 4644189 ↗

Other Microvention, Inc. products

• Azur CX Detachable22 models · 509 reports · 1 recall
• Stent63 models · 237 reports · 2 recalls
• Azur Detachable Helical HydroCoil42 models · 190 reports
• V-Trak75 models · 147 reports
• WEB14 models · 134 reports
• AZUR14 models · 104 reports
• HydroSoft 3D26 models · 101 reports
• ERIC Retrieval Device3 models · 5 reports · 1 recall