Home › Device types › DXE
Catheter, Embolectomy
FDA product code DXE · Class 2 · Cardiovascular
588
Registered devices
7,736
Adverse events
57
Recalls
74
510(k) clearances
Devices with this code
FETCH 2 — Bayer Healthcare LLCLarge Bore 60 cc Syringe — Inari Medical, Inc.LMI ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INCSyntel Silicone Embolectomy Catheter — Lemaitre Vascular, Inc.LeMaitre Embolectomy Catheter — Lemaitre Vascular, Inc.AMPLATZ GOOSE NECK™ — EV3, INCBARD Latex-free Arterial Embolectomy Catheters — APPLIED MEDICAL RESOURCES CORPORATIONARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDBiosensors Embolectomy Catheter — BIOPTIMAL INTERNATIONAL PTE. LTD.SPIROFLEX — Bayer Healthcare LLCLMI ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INCLMI THROMBECTOMY CATHETER — LUCAS MEDICAL INCSPIROFLEX VG — Bayer Healthcare LLCAMPLATZ GOOSE NECK — Covidien LPASAPLP™ — Merit Medical Systems, Inc.PRONTO — TELEFLEX INCORPORATEDLeMaitre Embolectomy Catheter — Lemaitre Vascular, Inc.Syntel Silicone OTW Embolectomy Catheter — Lemaitre Vascular, Inc.Biosensors Embolectomy Catheter — BIOPTIMAL INTERNATIONAL PTE. LTD.MegaVac Mechanical Thrombectomy System — CAPTURE VASCULAR, INC.ARROW — TELEFLEX INCORPORATEDPRONTO — TELEFLEX INCORPORATEDAMPLATZ GOOSE NECK — Covidien LP
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | PFM MEDICAL INC. | A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requir |
| 2025-04-11 | LeMaitre Vascular, Inc. | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| 2024-04-17 | LeMaitre Vascular, Inc. | The guide tip can become damaged and result in the tip detaching. |
| 2023-09-07 | Edwards Lifesciences, LLC | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). |
| 2022-10-06 | Edwards Lifesciences, LLC | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. |
| 2022-10-06 | Edwards Lifesciences, LLC | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. |
| 2022-09-30 | LeMaitre Vascular, Inc. | Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip towa |
| 2021-09-20 | Arrow International Inc | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional interven |
| 2021-09-20 | Arrow International Inc | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional interven |
| 2021-09-20 | Arrow International Inc | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional interven |
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