Euphora Semi-Compliant Rapid Exchange Balloon Dilatation Catheter 의 안전성 경고

Safety alert

2017-07-14

2017-07-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170714.html

Medical device safety alert: medtronic euphora semi-compliant rapid exchange balloon dilatation catheter medical device manufacturer, medtronic, has issued a medical device safety alert concerning its euphora semi-compliant rapid exchange (rx) balloon dilatation catheter. the affected devices are identified as follows:- model numbers: eup1506x, eup1510x, eup1512x, eup1515x, eup1520x, eup2006x, eup2010x, eup2012x, eup2015x, eup2020x, eup2025x, eup2030x, eup22506x, eup22510x, eup22512x, eup22515x, eup22520x, eup22525x, eup2506x, eup2510x, eup2512x, eup2515x, eup2520x, eup2525x, eup2530x, eup27506x, eup27510x, eup27512x, eup27515x, eup27520x, eup27525x, eup3006x, eup3010x, eup3012x, eup3015x, eup3020x, eup3025x, eup3030x, eup32506x, eup32510x, eup32512x, eup32515x, eup32520x, eup32525x, eup3506x, eup3510x, eup3512x, eup3515x, eup3520x, eup3525x, eup3530x, eup37506x, eup37510x, eup37512x, eup37515x, eup37520x, eup37525x, eup4006x, eup4010x, eup4012x, eup4015x, eup4020x, eup4025x, eup4030x lot number: 212553130 to 213283557 expiration date: 4 january 2019 to 9 may 2019 the manufacturer has initiated a voluntarily recall of select lot numbers of the medtronic euphora semi-compliant rx balloon dilatation catheter due to reports of difficulties in removing the stylette. in the event, there is the potential for damage to the balloon or catheter due to excessive force being applied, and this may lead to balloon inflation or deflation challenges. potential risks include prolonged procedure time and the need for additional intervention. in addition, inflation or deflation difficulties or catheter damage during procedural use could result in vessel occlusion or injury. according to the manufacturer, they have received one report of patient injury related to this matter. as the issue is experienced at the time of product use, there is no additional action related to the recall for patients who have previously been treated with potentially affected product. the patients should continue to be monitored in accordance with the facility’s standard care protocols. the medtronic nc euphora non-compliant rx balloon dilatation catheters are not affected by the issue. the affected users are advised to immediately stop using devices from the affected lots and return all unused products to the manufacturer for replacement. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 july 2017.