WaveSelect GW1410Recalls & reported problems
Enlight Medical Technologies(Shenzhen) Co., Ltd. · Class 2 · Implant
Data updated Oct 16, 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 06945258302114), received between Dec 8, 2025 and Dec 8, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PHYSICIAN WAS TREATING AN ACUTE SUBDURAL HEMATOMA ON A (B)(6) YEAR OLD FEMALE PATIENT AND WAS ADVANCING THE GUIDEWIRE THROUGH A HEADWAY DUO 167CM (TERUMO) AND AS HE WAS ADVANCING, HE REPORTED A PERFORATION IN THE MMA ARTERY. THE PHYSICIAN USED TRUFILL (CERENOVUS) AND KANEKA I-ED COILS TO STOP BLEEDING DUE TO PERFORATION. PATIENT SAFELY WOKE UP AND DIDNT SHOW VISUAL / PHYSICAL DEFICITS POST PROCEDURE. ON (B)(6) 2025 THE PHYSICIAN ADVISED THAT THE PATIENT IS STABLE AND THERE HAS BEEN NO CHANGE IN THE OUTCOME POST PROCEDURE. MFR REPORT# 3034543750-2025-00001.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743272 ↗
Other Guide, Wire, Catheter, Neurovasculature devices
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- Synchro SELECT SSTD215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall16 reports
- Synchro SELECT SSUP215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall11 reports
- Synchro2 S2SPS14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall1 death6 reports
- Synchro SELECT SSUP300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall5 reports
- Synchro2 S2SPP14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall2 reports
- Synchro SELECT SSFT300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall0 reports
- Mirage 103-0608Micro Therapeutics, Inc. · Guide, wire, catheter, neurovasculature12 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.
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