Devices

Device Recall EZ Steer ThermoCool Nav

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 15221536M, 15215004M, 15215001M, 15215000M, 15208579M, 15208577M, 15208574M, 14069262A, 14069168A, 14069084A, 15164269, 15164264, 15159917, 15159912, 15156608, 15148849, 15144223, 15128115, 15128113, 15119884, 15119883, 15116509, 15116506, 15103250, 15098193, 15098191, 15098190, 15095199, 15083389, 15083386, 15080818, 15080815, 15070703, 15067809, 15064960, 15032155, 15014525, 15014522, 15014521, 15010028, 15010027, 15007251, 15007250, 14152525, 14149131, 14149130, 14149129, 14146082, 14142307, 14138855, 14138853, 14138846, 14138795, 14120030, 14117394, 14117388, 14117385, 14117376, 14117371, 14117370, 14117356, 14113251, 14113249, 14109218, 14109216, 14102071, 14102068, 14097083, 14095220, 14093166, 14092574, 14091435, 14089642, 14089641, 14088995, 14087721, 14080304, 14080303, 14080302, 14079405, 14078387, 14078385, 14077789, 14075460, 14075459, 14071639, 14071638, 14071542, 14070108, 14068526, 14067399, 14065778, 14065064, 14065059, 14064262, 14064259, 14064258, 14063230, 14062655, 14062654, 14062652, 14062651, 14062042, 14062040, 14062039, 14062038, 14061249, 14060315, 14060311, 14058856, 14058855, 14057214, 14056275, 14056273, 14056272, 14053738, 14053167, 14052547, 14052249, 14051584, 14043263, 14042518, 14042517, 14038851, 14036716, 14036583, and 14036582
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. || The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.
  • Manufacturer
    Biosense Webster, Inc.
  • 1 Event

제조사

Biosense Webster, Inc.
  • 제조사 주소
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA

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데이터에 대해 더 자세히 알아보기 여기

Device Recall EZ Steer ThermoCool Nav
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 14050236, 14069164, 14085850, 14085852, 14089636, 14098511, 14102112, 14138785, 14142301, and 15091243
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. || The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.
  • Manufacturer
    Biosense Webster, Inc.
Device Recall EZ Steer ThermoCool Nav
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 15214996M, 14070102A, 15177599, 15156690, 15156649, 15123384, 15111287, 15079216, 15076033, 15070702, 14138791, 14117351, 14117345, 14117339, 14113236, 14109201, 14102119, 14102116 14093807, 14091431, 14087720, 14081176, 14077787, 14076743, 14075452, 14071539, 14071538, 14068519, 14066570, 14064255, 14060307, 14058853, 14058117, 14056270, 14056269, 14053165, 14052248, 14052247, 14049472, 14043262, 14040370, 14039651, and 14036714
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. || The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.
  • Manufacturer
    Biosense Webster, Inc.
Device Recall EZ Steer ThermoCool Nav
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 15076036, 15076035, 15059708, 14113238, 14105865, and 13439370
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. || The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.
  • Manufacturer
    Biosense Webster, Inc.
Device Recall EZ Steer ThermoCool Nav
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 15219359M, 15219356M, 15214930M, 15214908M, 15214902M, 15208638M, 15208634M, 15208631M, 15208628M, 15208626M, 15208619M, 15208612M, 15208607M, 15208593M, 15205050M, 15205047M, 15205031M, 15205018M, 15204883M, 15199820M, 15199819M, 15199811M, 15199801M, 15199794M, 15199792M, 14069263A, 15171668, 15171665, 15171663, 15171652, 15169965, 15169957, 15169946, 15164293, 15164271, 15159938, 15159935, 15159922, 15156563, 15151976, 15148785, 15148772, 15144234, 15144151, 15144134, 15144119, 15136209, 15132418, 15128133, 15128123, 15124171, 15124167, 15123408, 15120034, 15120022, 15116441, 15103256, 15103255, 15098206, 15098200, 15098198, 15098195, 15095224, 15095223, 15095220, 15091259, 15091254, 15083409, 15081335, 15081333, 15076058, 15076049, 15076046, 15071044, 15070717, 15070708, 15067823, 15067817, 15057475, 15040868, 15035767, 15035766, 15032160, 15028721, 15028712, 15028708, 15028701, 15025094, 15021180, 15021179, 15021175, 15021168, 15021164, 15021163, 15021148, 15017983, 15010043, 15010040, 15010033, 15010006, 15009982, 15009980, 15009978, 15009975, 15007267, 15007261, 15007255, 15007254, 14152530, 14149138, 14149136, 14146104, 14146099, 14146095, 14146090, 14146086, 14146084, 14142340, 14142339, 14142335, 14142333, 14142326, 14142325, 14142324, 14142323, 14142322, 14142317, 14142316, 14142314, 14142312, 14142311, 14138878, 14138878, 14138871, 14138866, 14138865, 14138864, 14138860, 14138859, 14120108, 14120105, 14120100, 14120092, 14120078, 14120076, 14120075, 14120067, 14120062, 14120055, 14120015, 14120014, 14120010, 14120006, 14120002, 14120000, 14119986, 14119985, 14119977, 14117438, 14117431, 14117430, 14117429, 14117409, 14117406, 14117404, 14117400, 14117398, 14113274, 14113268, 14113262, 14113257, 14109239, 14109234, 14109231, 14109230, 14109229, 14109228, 14102076, 14099138, 14099135, 14098716, 14098709, 14098706, 14098530, 14098525, 14097835, 14095223, 14090358, 14089643, 14088997, 14088996, 14087736, 14087731, 14085863, 14085143, 14085142, 14085141, 14081912, 14081911, 14081907, 14081809, 14081808, 14081805, 14081804, 14081185, 14080312, 14080310, 14079411, 14078390, 14076755, 14076256, 14076254, 14076253, 14075465, 14075464, 14071644, 14071547, 14068530, 14066590, 14066582, 14065792, 14065065, 14064778, 14064271, 14064266, 14064265, 14063238, 14063236, 14063234, 14062663, 14062660, 14062044, 14061259, 14061256, 14060323, 14060321, 14060320, 14058864, 14058857, 14058125, 14058124, 14058122, 14057221, 14057220, 14053745, 14053740, 14053739, 14053728, 14053724, 14053709, 14053168, 14052551, 14050933, 14049476, 14043896, 14042520, 14039654, 14038050, 14029870, 14029043, 14028071, 14027237, 14025878, 14025127, 14019684, 14016117, and 13435854
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. || The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.
  • Manufacturer
    Biosense Webster, Inc.