Surpass Elite FDSE50040Recalls & reported problems
Stryker Corporation · Flow Diverter System · Class 3 · Implant
All models of Surpass Elite (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327583151), received between Oct 14, 2024 and Feb 17, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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
- Difficult to Remove1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Difficult to Remove
IT WAS REPORTED THAT DURING ANEURYSM TREATMENT PROCEDURE, THE SUBJECT STENT WOULD NOT RESHEATH DESPITE MULTIPLE ATTEMPTS WITH MICROCATHETER. PHYSICIAN EVENTUALLY GAVE UP ON RESHEATHING AND DEPLOYED THE STENT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24361529 ↗InjuryOct 14, 2024Malposition of Device; Malposition of Device
IT WAS REPORTED THAT DURING THE ANEURYSM PROCEDURE IN THE VERTEBROBASILAR ARTERY THE SUBJECT FLOW DIVERTER EXPERIENCED TWISTING/KINKING FOLLOWING DEPLOYMENT. A CATHETER WAS USED TO OPEN THE PINCH POINT AS A MEDICAL INTERVENTION. THE SUBJECT FLOW DIVERTER DID FULLY APPOSE AGAINST THE VESSEL WALLS AT THE END OF THE PROCEDURE. BALLOON ANGIOPLASTY WAS USED POST SUBJECT STENT DEPLOYMENT. THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20438791 ↗
Other Intracranial aneurysm flow diverter devices
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- PIPELINE PED-500-20Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall31 reports
- PIPELINE PED-500-35Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death29 reports
- PIPELINE PED-500-16Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall2 deaths27 reports
- PIPELINE PED-500-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death23 reports
- PIPELINE PED-500-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall21 reports
- PIPELINE PED-450-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall20 reports
- PIPELINE PED-475-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death19 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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