Home › Device types › DXE
Catheter, Embolectomy
FDA product code DXE · Class 2 · Cardiovascular
591
Registered devices
7,841
Adverse events
58
Recalls
74
510(k) clearances
Devices with this code
ARROW — TELEFLEX INCORPORATEDLMI THROMBECTOMY CATHETER — LUCAS MEDICAL INCLeMaitre Embolectomy Catheter — Lemaitre Vascular, Inc.Indigo — PENUMBRA, INC.BARD Latex-free Arterial Embolectomy Catheters — APPLIED MEDICAL RESOURCES CORPORATIONIndigo System — PENUMBRA, INC.Indigo System — PENUMBRA, INC.FOGARTY FORTIS — Edwards Lifesciences LLCARROW — TELEFLEX INCORPORATEDASAP® — Merit Medical Systems, Inc.FOGARTY — Edwards Lifesciences LLCIndigo System — PENUMBRA, INC.LMI OCCLUSION CATHETER — LUCAS MEDICAL INCLMI ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INCSyntel Silicone OTW Embolectomy Catheter — Lemaitre Vascular, Inc.FETCH 2 — Bayer Healthcare LLCLMI ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INCFOGARTY — Edwards Lifesciences LLCAMPLATZ GOOSE NECK™ — EV3, INCLeMaitre Embolectomy Catheter — Lemaitre Vascular, Inc.AMPLATZ GOOSE NECK™ — EV3, INCAspire Max 5 Aspiration Catheter 55cm — ZIEN MEDICAL TECHNOLOGIES, INC.LMI ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INCLMI ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-28 | LeMaitre Vascular, Inc. | Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. |
| 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 |
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