SurVeil DCB SRV03513504015Recalls & reported problems
Surmodics, Inc. · SurVeil DCB 4.0mm x 150mm x 135cm · Class 3
Data updated Oct 16, 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 00812339030388), received between Nov 19, 2025 and Nov 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionNov 19, 2025Fracture; Fracture
A 4.0MM X 150MM X 135CM SURVEIL DRUG-COATED BALLOON (LOT W240003) WAS USED TO TREAT A LESION IN THE COMMON FEMORAL ARTERY OF A 58-YEAR-OLD FEMALE PATIENT WITH A RELEVANT HISTORY OF DIALYSIS, HYPERTENSION, PERIPHERAL ARTERY DISEASE, CORONARY ARTERY DISEASE, HYPERCHOLESTEROLEMIA, AND DIABETES. DURING THE PROCEDURE, A NON-ABBOTT CLOSURE DEVICE WAS PRESENT PROXIMALLY IN THE ANATOMY. THE SURVEIL BALLOON WAS ADVANCED TO THE TARGET LESION AND INFLATED AS INTENDED. UPON INFLATION, A LOSS OF PRESSURE WAS NOTED AND BALLOON RUPTURE WAS SUSPECTED. THERE WAS RESISTANCE ENCOUNTERED WITH THE CLOSURE DEVICE DURING REMOVAL; THE BALLOON WAS PULLED AWAY FROM THE DEVICE BUT DID NOT DETACH, AND THE ENTIRE DEVICE WAS REMOVED FROM THE ANATOMY AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THE PROCEDURE WAS COMPLETED AT THAT POINT. NO ADDITIONAL CLINICAL CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595544 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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