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精选安全与合规美国 FDAT1084

Early Alert: Catheter Introducer Issue from Abiomed and Oscor

·1 个月前·来源:美国 FDA

🤖 AI 摘要

Abiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.

分析模型:rule-based-v3 · 07-09 06:59

评分详情

综合分 84/100

信源权威

95

影响范围

75

时效性

50

合规紧急

90

行业关注

90

MedWatch Safety Alerts (医疗产品安全警报)
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