Boston Scientific stent recall is Class I | 合法醫療器材資訊網

2021年5月21日—“BostonScientificvoluntarilyinitiatedaglobalremovalofallnon-implantedVICIandVICIRDSvenousstentsystemsinApril2021dueto ...

The FDA announced today that it deemed Boston Scientific’s[1] recall of its VICI SDS and VICI RDS venous stent systems as Class I, the most serious kind of recall.

Marlborough, Mass.-based Boston Scientific’s VICI SDS and VICI RDS venous stent systems treat obstructions and occlusions in narrowed or blocked venous veins. According to the FDA notice[2], the company recalled the stent systems following reports indicating that they may migrate or move from where they are initially implanted.

To date, there have been 17 complaints and reported injuries related to the issue of migration with the stents. No deaths have been reported, however.

Boston Scientific initiated the recall on April 12, 2021, with 31,798 affected devices distributed between Sep. 21, 2018, and April 9, 2021, included in the U.S. recall.

If a stent migrates or moves from the initial implant location, ...

Boston Scientific Recalls Stent Systems Due to Migration Risk ... | 合法醫療器材資訊網

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

相關資訊整理

Boston Scientific Recalls Stent Systems Due to Migration Risk ... | 合法醫療器材資訊網

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

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

Boston Scientific Corporation Recalls VICI VENOUS STENT ... | 合法醫療器材資訊網

Boston Scientific stent recall is Class I | 合法醫療器材資訊網

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

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

Recalls Initiated for Boston Scientific&#39;s Vici and BD&#39;s Venovo ... | 合法醫療器材資訊網

FDA Advisory No.2021-1242 | 合法醫療器材資訊網

Boston Scientific recalls venous stents because of migration ... | 合法醫療器材資訊網

Recalls Initiated for Boston Scientific's Vici and BD's Venovo ... | 合法醫療器材資訊網