Syntel Embolectomy Catheter (Regular Tip) A4405Recalls & reported problems
Applied Medical Resources Corporation · Embolectomy/thrombectomy balloon catheter · 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 00607915110840), received between Jul 26, 2016 and Jul 26, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2016Break; Break
FEMORAL CUT DOWN WITH THROMBECTOMY. POSSIBLE STENT PLACEMENT REPORT FROM CUSTOMER: "CATHETER WENT THROUGH GROIN FOR ACCESS TO THE THROMBUS. TIP OF BALLOON BROKE OFF WHEN MOVING THE CATHETER. BALLOON TIP BROKE OFF INSIDE OF THE PATIENT. THE BALLOON IS NOT ON THE DEVICE. THEY WERE NOT ABLE TO RETRIEVE IT." TYPE OF INTERVENTION: "DID NOT OPEN A SECOND UNIT." PATIENT STATUS: "PATIENT IS IN RECOVERY."
Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient
MAUDE report 5824063 ↗
Other Catheter, Embolectomy devices
- Indigo System CAT6Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths408 reports
- Indigo System CATRXKITPenumbra, Inc. · Catheter, Embolectomy1 death339 reports
- Fogarty 120804FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall1 death200 reports
- LeMaitre Embolectomy Catheter 1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall161 reports
- FOGARTY 120404FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall61 reports
- Indigo System CAT6KIT-APenumbra, Inc. · Catheter, Embolectomy109 reports
- LeMaitre Embolectomy Catheter e1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy2 recalls4 reports
- Indigo System CAT8XTORQ115Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths98 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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