Product code DXE— Cardiovascular

Death

27

Injury

258

Malfunction

2,266

Total

2,551

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K240078 — Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC·2024-08-28
• K241330 — Fogarty Fortis Arterial Embolectomy CatheterEdwards Lifesciences·2024-07-02
• K233819 — Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLC·2024-05-22
• K233820 — Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards Lifesciences·2024-05-22
• K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards Lifesciences·2024-05-20
• K213771 — Merlin Aspiration SystemMivi Neurovascular, Inc.·2022-01-27
• K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation·2021-09-07
• K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeEdwards Lifesciences, LLC·2020-06-12
• K163031 — Bunegin-Albin Air Aspiration SetCook Incorporated·2017-07-27
• K163353 — Needle's Eye Snare Retrieval Set - 54cmCook Incorporated·2017-07-11
• K152335 — Export Advance Aspiration CatheterMedtronic, Inc.·2015-09-18
• K100840 — EMBO PLUS EMBOLECTOMY CATHETERHotspur Technologies·2010-07-12
• K100842 — PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CMHotspur Technologies·2010-07-12
• K081573 — MEDTRONIC EXPORT AP CATHETERMedtronic Vascular·2008-06-27
• K022145 — OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302LeMaitre Vascular, Inc.·2003-01-14
• K020634 — MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETERAtrium Medical Corp.·2002-05-08
• K011783 — MULTI-SNARE SETPfm Produkte Fur Die Medizin AG·2002-01-24
• K002627 — ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETERAtrium Medical Corp.·2001-04-26
• K992933 — LEMAITRE IRRIGATION CATHETERVascutech, Inc.·2000-03-08
• K992934 — LEMAITRE VENOUS THROMBECTOMY CATHETERVascutech, Inc.·2000-03-01
• K992940 — LEMAITRE BALLOON CATHETER WITH IRRIGATIONVascutech, Inc.·2000-02-22
• K992368 — LEMAITRE EMBOLECTOMY CATHETERVascutech, Inc.·1999-12-09
• K973477 — BIOSENSORS EMBOLECTOMY CATHETERSunscope Intl., Inc.·1998-09-04
• K982141 — ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025Arrow Intl., Inc.·1998-08-31
• K971314 — DCAT EMBOLECTOMY CATHETER SYSTEMAngioDynamics, Inc.·1998-03-17
• K972511 — AMPLATZ GOOSE NECK SNARE KIT/ CATHETERMicrovena Corp.·1998-03-06
• K973465 — LATIS GRAFT CLEANING CATHETERApplied Medical Resources·1998-02-19
• K974335 — EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.J-Lloyd Medical, Inc.·1998-02-13
• K972572 — SINGLE LUMEN EMBOLECTOMY CATHETERAmerican Biomed, Inc.·1998-01-13
• K972623 — LMI IRRIGATION CATHETER (IGR)Lucas Medical, Inc.·1997-11-19
• K970657 — LMI THROMBECTOMY CATHETERLucas Medical, Inc.·1997-07-01
• K970762 — DUAL LUMEN EMBOLECTOMY CATHETERApplied Medical Resources·1997-03-28
• K961883 — VERSA-CATH ARTERIAL CATHETERIdeas For Medicine, Inc.·1997-01-13
• K961992 — NEEDLE'S EYE SNARECook Pacemaker Corp.·1996-12-27
• K961716 — VASO-SAFE ARTERIAL EMBOLECTOMY CATHETEIdeas For Medicine, Inc.·1996-09-19
• K954760 — LMI ARTERIAL EMBOLECTOMY CATHETERLucas Medical, Inc.·1996-04-11
• K955125 — LMI OCCLUSION CATHETERLucas Medical, Inc.·1996-03-11
• K950586 — AVD INTIMAX THROMBECTOMY CATHETERApplied Medical Resources·1995-05-15
• K935405 — ARTERIAL EMBOLECTOMYJ-Lloyd Medical, Inc.·1994-07-25
• K920823 — WELTER SNARE RETRIEVERCook, Inc.·1993-03-04
• K920871 — J-LLOYD ARTERIAL EMBOLECTOMY CATHETERJ-Lloyd Medical, Inc.·1993-02-26
• K914880 — DUAL BALLOON EMBOLECTOMY CATHETERIdeal Medical, Inc.·1992-03-16
• K910372 — INTIMAX THROMBECTOMY CATHETERApplied Vascular Devices, Inc.·1991-04-26
• K902327 — EMBOLECTOMY CATHETERClincal Instruments Corp.·1991-02-25
• K905139 — CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETERCathlab Corp.·1991-02-25
• K901502 — AMPLATZ GOOSE-NECK SNAREMicrovena Corp.·1990-12-03
• K901627 — ARTERIAL EMBOLECTOMY CATHETERApplied Vascular Devices, Inc.·1990-10-19
• K900311 — ARTERIAL EMBOLECTOMY CATHETERImpra, Inc.·1990-07-17
• K901625 — FOGARTY ARTERIAL EMBOLECTOMY II CATHETERBaxter Healthcare Corp·1990-07-06
• K897184 — 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERSCathlab Corp.·1990-03-14
• K883852 — CATHETER, CARDIOVASCULAR, BALLOON TYPEWb Intl., Inc.·1989-12-07
• K894681 — REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETERShiley, Inc.·1989-10-12
• K891021 — TRI-LUMEN INTRA VASCULAR BALLOON CATHETERIdeal Medical, Inc.·1989-09-18
• K893680 — SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.Cathlab Corp.·1989-08-01
• K892410 — FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETERBaxter Healthcare Corp·1989-07-20
• K881455 — EMBOLECTOMY CATHETER(MODIFIED)Cathlab Corp.·1988-06-15
• K872485 — CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)Ideas For Medicine, Inc.·1987-08-12
• K864062 — PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)Ideas For Medicine, Inc.·1987-01-06
• K864330 — SHEAR FORCE GAUGEAmerican Edwards Laboratories·1987-01-06
• K864007 — EMBOLECTOMY/THROMBECTOMY BALLOON CATHETERUresil Corp.·1987-01-02
• K853625 — NOVA ARTERIAL EMBOLECTOMY CATHETERNova Medical Specialties·1986-01-15
• K850015 — POLYMED LAB ARTERIAL EMBOLECTOMY CATHETERPolymed Laboratories·1985-06-19
• K840198 — ARTERIAL EMBOLECTOMY CATHETERShiley, Inc.·1984-08-03
• K832044 — SHILEY MULTIPRO CATHETERShiley, Inc.·1983-09-29
• K832023 — EMBOLECTOMY CATHETERBionomy, Inc.·1983-08-31
• K820646 — ATRAC TM MULTIPURPOSE BALLOON CATHETERAtrium Medical Corp.·1982-03-25
• K812640 — URE SIL EMBOLECTOMY/THROMBECTOMY CATHUresil Corp.·1981-10-02
• K801650 — DESERET EMBOLECTOMY/THROMBECTOMY CATH.Deseret Medical, Inc.·1980-08-04
• K790838 — ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)Shiley, Inc.·1979-06-11
• K780762 — EMBOLECTOMY CATHETER, EXTEND. SHELF LIFEShiley, Inc.·1978-05-26
• K780244 — CATHETERS, ARTERIAL EMBOLECTOMYExtracorporeal Medical Specialities, Inc.·1978-04-13
• K770714 — CATHETER, ARTERIAL EMBOLECTOMYMallinckrodt Critical Care·1977-04-27
• K770569 — CATHETER, EMBOLECTOMY, UMIUniversal Medical Instrument Corp.·1977-04-05
• K761031 — ELECATH ARTERIAL EMBOLECTOMY CATHETERElectro-Catheter Corp.·1976-12-13