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Medtronic Stent Graft System Recalled Due to Fractures ... | 合法醫療器材資訊網

Medtronic Stent Graft System Recalled Due to Fractures ...

2021年4月13日—TheFoodandDrugAdministration(FDA)hasannouncedaClassIrecalloftheMedtronicValiantNavion™thoracicstentgraftsystem,which ...

 Medtronic Stent Graft System Recalled Due to Fractures ...

The Food and Drug Administration (FDA) has announced a Class I recall of the Medtronic Valiant Navion™ thoracic stent graft system, which was distributed between November 12, 2018 and February 10, 2021.

The Valiant Navion™ thoracic stent graft system is designed for the endovascular repair of lesions in the descending thoracic aorta. When placed within the aorta, the stent graft provides an alternative path for blood flow within the patient’s vasculature by excluding the lesion from blood flow and pressure.

The recall was initiated due to reports of stent fractures and endoleaks. Thus far, there have been 11 reported issues, including 4 cases of Type III endoleak, 4 cases of stent fracture, and 7 cases of stent ring enlargement; among these reports, there have been 2 injuries and 1 death.

Clinicians should immediately cease using the stent graft system and follow instructions for returning unused product to Medtronic[1]. A...

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Recall 2020 FDA recall classification FDA Medical device Medical Device Recalls Medical device safety MedWatch: The FDA Safety Information and Adverse Event Reporting Program ROSA FDA Medtronic TEVAR FDA medical device FDA Class 2 medical device fda查詢 FDA Listing FDA Guidance Medical device FDA Medical Device classification Medical device safety FDA recall Medical device list Recall 2020 Maude FDA CDRH medical device safety standards medical device safety act medical product safety medical device safety testing medical device safety alert fda medical device safety communications medical device safety alert fda definition FDA FDA Safety FDA adverse event FDA SRP 1-800-FDA-1088 FDA 進度查詢 FAERS 星辰血壓計評價 MEDTRONIC LEGACY stryker laparoscopy surgical suction irrigation system 宇盛儀器股份有限公司 羅氏免疫分析總三碘甲狀腺素檢驗試劑 “帝視”壓舌板 (未滅菌) cleia test
Boston Scientific Recalls Stent Systems Due to Migration Risk ... | 合法醫療器材資訊網
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2021 Medical Device Recalls | 合法醫療器材資訊網
List of Medical Device recalls in 2021. ... Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for ... 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 — On February 12, 2021, Medtronic sent an Urgent Medical Device Recall notification to all affected customers. Recommendations were offered to ... Read More
Boston Scientific Corporation Recalls VICI VENOUS STENT ... | 合法醫療器材資訊網
2021年5月21日 — There is a recall because the stents may migrate after implantation. ... Dates: September 21, 2018 to April 9, 2021; Devices Recalled in the U.S.: ... Read More
Boston Scientific stent recall is Class I | 合法醫療器材資訊網
2021年5月21日 — “Boston Scientific voluntarily initiated a global removal of all non-implanted VICI and VICI RDS venous stent systems in April 2021 due to ... Read More
Medtronic Stent Graft System Recalled Due to Fractures ... | 合法醫療器材資訊網
2021年4月13日 — The Food and Drug Administration (FDA) has announced a Class I recall of the Medtronic Valiant Navion™ thoracic stent graft system, which ... Read More
FDA Medical Device Recalls in 2021 | 合法醫療器材資訊網
2021年6月18日 — The company recalled the test kits because of a likely risk of false results. Boston Scientific Stent: Recall Date: May 21,2021. The FDA announced ... Read More
Recalls Initiated for Boston Scientific's Vici and BD's Venovo ... | 合法醫療器材資訊網
2021年5月26日 — May 26, 2021—Device recalls of venous stents were recently initiated by Boston Scientific Corporation and Bard Peripheral Vascular, Inc., ... Read More
FDA Advisory No.2021-1242 | 合法醫療器材資訊網
2021-1242 || Voluntary Recall of Medtronic Valiant Naviation™ Thoracic Stent Graft System. Share this Post! The Food and Drug Administration ( ... Read More
Boston Scientific recalls venous stents because of migration ... | 合法醫療器材資訊網
2021年5月24日 — Boston Scientific's pursuit of the venous stent opportunity has suffered a setback. The company is recalling all 31,798 Vici SDS and Vici RDS ... Read More
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