AtriCure Isolator Synergy EnCompass Clamp and GuideSystem GPM100Recalls & reported problems
Atricure, Inc. · Glidepath Magnetic Guide · 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 10840143904134), received between Jun 16, 2023 and Jun 16, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation 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.
Most reported problems
Device problems
- Separation 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.
MalfunctionJun 16, 2023Separation Problem; Separation Problem
A PATIENT UNDERWENT AN ON-PUMP CORONARY ARTERY BYPASS GRAFT PROCEDURE VIA MEDIAN STERNOTOMY WITH CONCOMITANT POSTERIOR WALL ENCIRCLING ABLATION UTILIZING THE ENCOMPASS CLAMP. WHEN REMOVING THE GLIDEPATH TAPE, IT WAS OBSERVED THAT THE GPM100 RED RUBBER WAS FRACTURED AT THE CONNECTION POINT TO THE MAGNETIC TIP. THERE WAS NO REPORTED SERIOUS INJURY TO THE PATIENT DURING THE PROCEDURE. IF THIS MALFUNCTION WERE TO RECUR, IT MAY HAVE THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17147757 ↗
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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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