Syntel Embolectomy Catheter (Spring Tip) A4F06Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915111090), received between Mar 6, 2017 and Mar 6, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (3 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
- Burst Container or Vessel3
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel
BRACHIAL EMBOLECTOMY: "BALLOON BURST UPON INFLATION." PATIENT STATUS - UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6382127 ↗MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel
BRACHIAL EMBOLECTOMY: "BALLOON BURST UPON INFLATION." PATIENT STATUS - UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6382126 ↗MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel
BRACHIAL EMBOLECTOMY: "BALLOON BURST UPON INFLATION." PATIENT STATUS - UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6382123 ↗
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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