Sundt™ NL8505070Recalls & reported problems
Integra Lifesciences Corporation · Sundt™ External Carotid Endarterectomy Shunt · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780026259), received between Mar 27, 2025 and Mar 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device 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.
MalfunctionMar 27, 2025Use of Device Problem; Use of Device Problem
A FACILITY REPORTED THAT WHEN PLACING THE SUNDT EXTERNAL SHUNT (NL8505070), THE SURGEON OBSERVED AN ISSUE AND HAD TO CHANGE THE SHUNT QUICKLY. THE CAROTID ARTERY WAS CLAMPED AT THE TIME OF THE OCCURRENCE. THERE WAS NO ALLEGATION OF PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATING THE FOLLOWING: DO YOU HAVE MORE DETAILS ON THE ISSUE FACED? SHUNT WAS FLATTENED. - DID THE ISSUE CAUSE ANY INCREASE OF SURGICAL TIME EQUAL OR SUPERIOR TO 30 MINUTES)? NO INCREASED TIME REPORTED AS DEVICES CHANGED AT THE BEGINNING OF THE PROCEDURE. HOW DID THEY FINALIZE THE SURGERY? USE OF ANOTHER DEVICE AVAILABLE IN STOCK? >> YES - "AS PER RISK ASSESSMENT PERFORMED BY OUR CLINICIAN TEAM, THIS CASE IS CONSIDERED AS REPORTABLE. POTENTIAL FOR DEATH OR SERIOUS INJURY IS NOT REMOTE. FLATTENED CAROTID SHUNT MAY IMPEDE OR REDUCE BLOOD FLOW TO THE HEAD AND BRAIN. THEREFORE, POTENTIAL RISK FOR SERIOUS INJURY IS NOT REMOTE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708976 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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