FOGARTY 220804FRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY IRRIGATION CATHETER 4F, 80CM · Class 1
All models of FOGARTY (32)
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 00690103043594), received between Nov 17, 2020 and Nov 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2020Material Rupture
PER THE REPORTER, WE WERE DOING A FEMORAL THROMBECTOMY USING A # 4 LONG FOGARTY CATHETER AND PART OF THE BALLOON BUSTED AND POTENTIALLY REMAINED IN THE PATIENT. WE HAVE SAVED THE BALLOON AND THE WRAPPER FOR FURTHER INVESTIGATION. PREVIOUS DAY SURGEON'S PROGRESS NOTE: LEGS ARE COOL, BUT PERFUSED. RIGHT GROIN INCISION IS CLEAN, DRY, AND INTACT. WILL MOVE LOWER EXTREMITY BUT MINIMAL STRENGTH. STABLE PERFUSION TO BOTH FEET. HIGH RISK FOR HIGHER AMPUTATION BILATERALLY.
Patient problems: Foreign Body In Patient
MAUDE report 10851262 ↗
Other CATHETER, IRRIGATION devices
- Navarre Opti-Drain NOD8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION901 reports
- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 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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