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“美敦力”優芙菈快速交換球囊擴張導管回收警訊
| 發布日期:2017-07-31 | 更新日期:2018-03-26 發布單位:醫療器材及化粧品組

“美敦力”優芙菈快速交換球囊擴張導管

回收警訊

許可證字號:衛部醫器輸字第028782

產品英文名稱:MedtronicEuphora Rapid Exchange Balloon Dilatation Catheter

受影響規格/型號/批號:

型號

產品型號敘述

Batch

EUP1506X

BALLOON EUP1506X EUPHORA RX OUS

212724801

212814775

212883766

213079350

213093649

EUP1510X

BALLOON EUP1510X EUPHORA RX OUS

212653765

212846670

212917141

EUP1512X

BALLOON EUP1512X EUPHORA RX OUS

212691113

212904354

212917099

EUP1515X

BALLOON EUP1515X EUPHORA RX OUS

212621111

212779633

212803279

212917140

212931098

212982902

EUP1520X

BALLOON EUP1520X EUPHORA RX OUS

212691105

212751953

212779760

EUP2006X

BALLOON EUP2006X EUPHORA RX OUS

212835758

212982866

EUP2010X

BALLOON EUP2010X EUPHORA RX OUS

212917089

EUP2012X

BALLOON EUP2012X EUPHORA RX OUS

212572603

212577130

212653771

EUP2015X

BALLOON EUP2015X EUPHORA RX OUS

212577124

212633102

212653767

212779638

213145987

EUP2020X

BALLOON EUP2020X EUPHORA RX OUS

212577128

212621104

212633108

212779634

212786713

212846667

EUP2030X

BALLOON EUP2030X EUPHORA RX OUS

212710898

212835756

212917098

EUP22510X

BALLOON EUP22510X EUPHORA RX OUS

212820846

EUP22512X

BALLOON EUP22512X EUPHORA RX OUS

212633103

212691109

212702007

212835759

212938413

EUP22515X

BALLOON EUP22515X EUPHORA RX OUS

212691108

212724810

212855158

212955146

EUP22520X

BALLOON EUP22520X EUPHORA RX OUS

212702003

212853377

EUP2506X

BALLOON EUP2506X EUPHORA RX OUS

212917092

EUP2510X

BALLOON EUP2510X EUPHORA RX OUS

212653772

212779632

213151448

EUP2512X

BALLOON EUP2512X EUPHORA RX OUS

212577127

EUP2515X

BALLOON EUP2515X EUPHORA RX OUS

212553133

212577126

212773500

212786709

212846668

212982876

EUP2520X

BALLOON EUP2520X EUPHORA RX OUS

212613020

212621110

212760548

212803425

EUP2530X

BALLOON EUP2530X EUPHORA RX OUS

212710897

212835803

EUP27512X

BALLOON EUP27512X EUPHORA RX OUS

212691111

212820596

212904348

EUP27515X

BALLOON EUP27515X EUPHORA RX OUS

212620619

212691110

212710900

212835806

212846675

212866532

212955147

EUP27520X

BALLOON EUP27520X EUPHORA RX OUS

212653769

212702011

212814777

212846666

212883768

212967570

EUP3010X

BALLOON EUP3010X EUPHORA RX OUS

212653768

212751955

EUP3012X

BALLOON EUP3012X EUPHORA RX OUS

212553134

212663243

212779761

212835805

213037302

EUP3015X

BALLOON EUP3015X EUPHORA RX OUS

212621101

212710902

212803424

212853374

212904357

212955152

EUP3020X

BALLOON EUP3020X EUPHORA RX OUS

212779636

212904355

212938420

EUP3030X

BALLOON EUP3030X EUPHORA RX OUS

212955143

EUP32515X

BALLOON EUP32515X EUPHORA RX OUS

212917094

EUP32520X

BALLOON EUP32520X EUPHORA RX OUS

212702005

EUP3510X

BALLOON EUP3510X EUPHORA RX OUS

212724802

212931088

EUP3512X

BALLOON EUP3512X EUPHORA RX OUS

212620618

212691103

212904346

EUP3515X

BALLOON EUP3515X EUPHORA RX OUS

212613021

212814776

212904351

EUP3520X

BALLOON EUP3520X EUPHORA RX OUS

212613018

212621105

212663241

212691106

212835804

212904353

EUP3530X

BALLOON EUP3530X EUPHORA RX OUS

212701874

EUP4010X

BALLOON EUP4010X EUPHORA RX OUS

212835755

212938408

EUP4012X

BALLOON EUP4012X EUPHORA RX OUS

212938404

EUP4015X

BALLOON EUP4015X EUPHORA RX OUS

212613017

212691104

212835800

212938406

EUP4020X

BALLOON EUP4020X EUPHORA RX OUS

212691114

212702015

212904347

212990788

 

發布對象:醫療從業人員/醫療器材專業人員

警訊說明:(回收/矯正原因描述)

美敦力總公司接獲半順應性優芙菈快速交換球囊擴張導管的管芯不易移除的通報。當發生管芯移除困難時,球囊或導管有可能因過度用力而損壞,造成球囊加壓或洩壓的困難。球囊加壓或洩壓困難對病患的潛在風險,包括手術時間延長及需要額外的處置。此外,在手術當中發生加壓與洩壓困難或導管損壞,可能導致病患的血管阻塞或損傷。

國內矯正措施:

經查,國內進口受影響產品數量共2,166支(銷售總數量:465支,庫存:1,701支)。美敦力醫療產品股份有限公司已於106年7月20日通知受影響客戶,預計於106年8月31日前完成回收。

廠商聯絡資訊:

公司名稱:美敦力醫療產品股份有限公司
聯絡電話: 02-21836134
聯絡人電子郵件:margaret.fu@medtronic.com