Syntel Embolectomy Catheter (Regular Tip) A4406Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915110857), received between Sep 21, 2016 and Oct 19, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2016Break; Break
TYPE OF INTERVENTION - "THEY JUST CHANGED CATHETER"
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6039027 ↗MalfunctionSep 21, 2016Break; Break
TYPE OF INTERVENTION - "THEY JUST CHANGED CATHETR".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5967082 ↗
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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