Medtronic hit with another Class I recall regarding HeartWare ... | 合法醫療器材資訊網

2021年5月12日—Medtronic'sHeartWareHVADsystem,whichhelpstheheartcontinuetopumpbloodtotherestofthebody,hasbeenplaguedwithissuesallyear.

Dive Brief: Another recall regarding Medtronics HeartWare HVAD system was labeled[1] a Class I event by the FDA on Wednesday, marking the systems third Class I recall of 2021 and fifth since 2018. The most recent recall is regarding instructions for use and patient manuals covering three aspects of the HeartWare HVAD system: HVAD carrying cases, the driveline covering orientation and the controller power-up sequence. The recall affects numerous HVAD models and product components. One death and 64 injuries have been reported due to the issues outlined by the FDA. A Medtronic spokesperson said in an emailed statement that customers were notified of the issues in February and the company is currently updating patient manuals and instructions for use. The recall is just related to the instructions and manuals; no items such as HVAD systems or components to systems are being impacted, ...

Medtronic Recalls HeartWare HVAD Battery Cables | 合法醫療器材資訊網

Medtronic | 合法醫療器材資訊網

2021年5月12日 — Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline ... Read More

Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or ... | 合法醫療器材資訊網

2021年3月1日 — Medtronic is recalling the HVAD Pump Implant Kit because the device may fail to initially start, restart, or have a delay in restarting ... Read More

Medtronic Stops Distribution and Sale of HeartWare HVAD ... | 合法醫療器材資訊網

2021年8月12日 — Recalled Product · HeartWare HVAD System · Model Numbers: See Full List of Affected Devices · Distribution Dates: August 30, 2016 to June 3, 2021 ... Read More

Medtronic Recalls HeartWare HVAD Pump Outflow Graft and ... | 合法醫療器材資訊網

2020年5月28日 — Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up. Read More

Medtronic's HeartWare HVAD pump recalls and decision to exit | 合法醫療器材資訊網

2021年6月17日 — Medtronic abruptly pulled its HeartWare Heart Ventricular Assist Device pump system from the market June 3 after a series of Class I recalls ... Read More

Medtronic hit with another Class I recall regarding HeartWare ... | 合法醫療器材資訊網

2021年5月12日 — Medtronic's HeartWare HVAD system, which helps the heart continue to pump blood to the rest of the body, has been plagued with issues all year. Read More

Medtronic pulls HeartWare HVAD pump from market amid ... | 合法醫療器材資訊網

2021年6月3日 — Medtronic abruptly pulled its HeartWare HVAD pump system from the market Thursday after a slew of Class I recalls and numerous reports of ... Read More

Medtronic Heartware Ventricular Assist Device System | 合法醫療器材資訊網

2021年6月25日 — The Medtronic HVADTM System was recalled because it could cause serious harm, including harm to the patient's brain and nervous system, and ... Read More

Medtronic Pulls the Plug on the HVAD System | 合法醫療器材資訊網

2021年6月3日 — In early March, MD+DI reported that Medtronic had recalled the pump implant kit for the HVAD because the device may fail to initially start, ... Read More

相關資訊整理

Medtronic Recalls HeartWare HVAD Battery Cables | 合法醫療器材資訊網

Medtronic | 合法醫療器材資訊網

Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or ... | 合法醫療器材資訊網

Medtronic Stops Distribution and Sale of HeartWare HVAD ... | 合法醫療器材資訊網

Medtronic Recalls HeartWare HVAD Pump Outflow Graft and ... | 合法醫療器材資訊網

Medtronic&#39;s HeartWare HVAD pump recalls and decision to exit | 合法醫療器材資訊網

Medtronic hit with another Class I recall regarding HeartWare ... | 合法醫療器材資訊網

Medtronic pulls HeartWare HVAD pump from market amid ... | 合法醫療器材資訊網

Medtronic Heartware Ventricular Assist Device System | 合法醫療器材資訊網

Medtronic Pulls the Plug on the HVAD System | 合法醫療器材資訊網

Medtronic's HeartWare HVAD pump recalls and decision to exit | 合法醫療器材資訊網