ABLATOR 7209652Recalls & reported problems
Smith & Nephew, Inc. · ABLATOR-S 2MM 60DEG · Class 2
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 03596010470409), received between Mar 15, 2021 and Mar 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.
Most reported problems
Device problems
- Delivered as Unsterile Product1
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 15, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT, WHEN THE PACKAGED WAS OPENED, THE ABLATION WAND WASN¿T INSIDE ANY STERILE PACKAGING. THE PACKAGE WAS DAMAGED. THE UNIT WAS NOT STERILIZED. INCIDENT OCCURRED WHILE SETTING-UP TO THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11489955 ↗
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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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