MICRUSPHERE SPH100350-20Recalls & reported problems
Medos International Sàrl · MICRUSPHERE microcoil MICRUSPHERE 10 Platinum Coil 3.5mm x 6.6cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of MICRUSPHERE (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528003533), received between Oct 13, 2017 and Sep 22, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Stretched” (3 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, 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 16, 2026.
Most reported problems
Device problems
- Stretched3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2021Stretched; Stretched
AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED EMBOLIZATION FOR ANEURYSMS UNDER GENERAL ANESTHESIA, A MICRUSPHERE 10 PLAT 3.5MMX6.6CM COIL (SPH10035020, 30358389) WAS ADVANCED THROUGH AN UNSPECIFIED MICROCATHETER (MC) AND ARRIVED AT TARGET POSITION, STARTED FILLING THE ANEURYSM WITH COIL. THE PHYSICIAN OBSERVED THAT COIL WAS FOUND TO BE UNRAVELED/STRETCHED IN THE MICROCATHETER. THEN RETRACTED THE COIL TO INTRODUCER AND THE SURGEON SWITCHED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12516273 ↗MalfunctionJul 23, 2018Stretched; Stretched
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE MICROSPHERE 10 PLATINUM COIL 3.5MM X 6.6CM (B)(4) WAS FOUND STRETCHED. THE COIL WAS WITHDRAWN AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR CONSEQUENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7712915 ↗MalfunctionOct 13, 2017Stretched; Stretched
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE MICRUSPHERE COIL (SPH10035020/P10043) STRETCHED. USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON THE PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6947136 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page