Medtronic Recalls Evera, Viva, Brava, Claria | 合法醫療器材資訊網

2021年4月12日—TheFDAhasidentifiedthisasaClassIrecall,themostserioustypeofrecall.Useofthesedevicesmaycauseseriousinjuriesordeath.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product Medtronic Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Models: Full List of Affected Devices below Serial Numbers: Full List of Affected Devices below Distribution Dates: August 31, 2012 to May 9, 2018 Devices Recalled in the U.S.: 239,171 Date Initiated by Firm: February 3, 2021 Device Use

Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or...

2021 Medical Device Recalls | 合法醫療器材資訊網

Device Name, Date. Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results, 07/07/21. Medtronic Vascular Recalls Angiographic ... Read More

Medtronic Recalls Evera, Viva, Brava, Claria | 合法醫療器材資訊網

2021年4月12日 — The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More

Medtronic Vascular Recalls Angiographic Guidewire ... | 合法醫療器材資訊網

2021年7月2日 — Medtronic Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile ... The FDA has identified this as a Class I recall, the most ... Read More

2020 Medical Device Recalls | 合法醫療器材資訊網

Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues, 11/03/20. Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump ... Read More

Stop New Implants of the Medtronic HVAD System – Letter to ... | 合法醫療器材資訊網

June 3, 2021. The U.S. Food and Drug Administration (FDA) is alerting health care providers that Medtronic has stopped the sale and distribution of the ... Read More

Medtronic Recalls Valiant Navion Thoracic Stent Graft System ... | 合法醫療器材資訊網

2021年4月9日 — The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More

FDA Alerts Health Care Providers to Stop New Implants of ... | 合法醫療器材資訊網

2021年6月3日 — FDA is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic's Heartware Ventricular Assist ... Read More

Medical Device Recalls | 合法醫療器材資訊網

Results 1 - 10 of 17 — used to interrogate cardiac implantable electronic devi...15, 2, 04/30/2021, Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). CRT- ... Read More

510(k) Premarket Notification | 合法醫療器材資訊網

Results 1 - 10 of 13 — ProductCode: LZG Applicant: MEDTRONIC MINIMED Decision Date To: 07/07/ ... medtronic minimed paradigm insulin pump, models mmt-515 and ... Read More

Premarket Approval (PMA) | 合法醫療器材資訊網

Super Search Devices@FDA ... APPROVAL FOR THE MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY WHICH INCLUDES THE MODEL 3387 DBS LEAD, MODEL 3389 DBS LEAD, ... Read More

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