Events

Device Recall Solarice Rapid Exchange Balloon Dilatation Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Vascular Galway DBA Medtronic Ireland 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    77976
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3137-2017
  • 사례 시작날짜
    2017-07-13
  • 사례 출판 날짜
    2017-09-20
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158617
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
  • 원인
    Stylette removal difficulties on the euphora and solarice products.
  • 조치
    Medtronic sent a communication informing their consignees about the recall and for the customers to take the following actions: Medtronics records indicate that your facility has received product potentially affected by this issue. As a result, Medtronic requests that you immediately take the following actions: 1. Identify and quarantine all unused affected product as listed in your inventory. 2. Return all unused affected listed product in your inventory to Medtronic. Contact Medtronic Customer Service at 888-283-7868 to initiate a product return and credit. Your local Medtronic Representative can assist you in the return and replacement of this product as necessary. 3. Complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and email to RS.CFQFCA@medtronic.com. Medtronic is communicating this information to the U.S. FDA and other appropriate regulatory agencies as required. Please share this notification with others who need to be aware in your organization or to any organization where affected product may have potentially been transferred. We are committed to acting responsibly in the best interest of patient safety. We sincerely appreciate your patience as it relates to this matter. If you have any questions, please contact your Medtronic Field Representative or Technical Services at 1-877-526-7890 Ext. 27220. Adverse reactions or quality problems experienced with the use of this product may be reported to your Medtronic Representative and the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Device

Device Recall Solarice Rapid Exchange Balloon Dilatation Catheter
  • 모델명 / 제조번호(시리얼번호)
    Product Number / CFN GTIN Lot SLC2525X 00643169680234 212610381 SLC3520X 00643169680449 212610395 SLC1520X 00643169680043 212610391 SLC2015X 00643169680081 212610384 SLC2020X 00643169680098 212621132 SLC2515X 00643169680210 212610388 SLC2520X 00643169680227 212621130 SLC4015X 00643169680531 212610378 SLC27520X 00643169680289 212621127 SLC27515X 00643169680272 212621128 SLC3515X 00643169680432 212621129 SLC3020X 00643169680340 212663250 SLC22510X 00643169680135 212671839 SLC3010X 00643169680319 212663249 SLC22506X 00643169680128 212671834 SLC2506X 00643169680180 212671836 SLC2025X 00643169680104 212671880 SLC37515X 00643169680487 212671833 SLC32515X 00643169680388 212671838 SLC4010X 00643169680517 212671837 SLC22520X 00643169680166 212663251 SLC3006X 00643169680302 212671835 SLC2020X 00643169680098 212691165 SLC2512X 00643169680203 212691118 SLC2515X 00643169680210 212691164 SLC2015X 00643169680081 212691160 SLC22512X 00643169680142 212691163 SLC2025X 00643169680104 212691167 SLC2020X 00643169680098 212702017 SLC2530X 00643169680241 212691173 SLC1512X 00643169680029 212691119 SLC2515X 00643169680210 212702018 SLC2015X 00643169680081 212702463 SLC2012X 00643169680074 212710905 SLC2030X 00643169680111 212710910 SLC2510X 00643169680197 212710908 SLC2512X 00643169680203 212702020 SLC2520X 00643169680227 212702019 SLC22520X 00643169680166 212702021 SLC2015X 00643169680081 212702016 SLC3030X 00643169680364 212691171 SLC2020X 00643169680098 212702465 SLC2012X 00643169680074 212709027 SLC2015X 00643169680081 212709026 SLC1520X 00643169680043 212702462 SLC2525X 00643169680234 212691168 SLC22525X 00643169680173 212691166 SLC2012X 00643169680074 212709723 SLC1512X 00643169680029 212702464 SLC2515X 00643169680210 212709726 SLC2512X 00643169680203 212709724 SLC3020X 00643169680340 212710906 SLC1510X 00643169680012 212710907 SLC1515X 00643169680036 212709725 SLC1520X 00643169680043 212709025 SLC4015X 00643169680531 212691162 SLC3512X 00643169680425 212710909 SLC4020X 00643169680548 212691170 SLC27525X 00643169680296 212691172 SLC1512X 00643169680029 212724814 SLC1506X 00643169680005 212724811 SLC1515X 00643169680036 212724813 SLC22515X 00643169680159 212724812 SLC3515X 00643169680432 212691169 SLC1512X 00643169680029 212752474 SLC2020X 00643169680098 212760551 SLC2015X 00643169680081 212760550 SLC2520X 00643169680227 212760552 SLC32512X 00643169680371 212751958 SLC2520X 00643169680227 212751959 SLC2006X 00643169680050 212752340 SLC3520X 00643169680449 212691161 SLC37520X 00643169680494 212751957 SLC2010X 00643169680067 212773513 SLC2015X 00643169680081 212796639 SLC3015X 00643169680333 212796634 SLC2515X 00643169680210 212773514 SLC2515X 00643169680210 212796637 SLC3020X 00643169680340 212796740 SLC2512X 00643169680203 212796633 SLC3510X 00643169680418 212796632 SLC3030X 00643169680364 212796635 SLC2530X 00643169680241 212796638 SLC1520X 00643169680043 212796636 SLC2020X 00643169680098 212796741 SLC2015X 00643169680081 212820860 SLC2515X 00643169680210 212820856 SLC2020X 00643169680098 212820861 SLC2520X 00643169680227 212820857 SLC2012X 00643169680074 212820850 SLC3020X 00643169680340 212820859 SLC3012X 00643169680326 212820853 SLC3010X 00643169680319 212820854 SLC3520X 00643169680449 212820851 SLC37512X 00643169680470 212820847 SLC27515X 00643169680272 212820849 SLC1515X 00643169680036 212820858 SLC2512X 00643169680203 212820852 SLC2020X 00643169680098 212835827 SLC22510X 00643169680135 212835833 SLC2520X 00643169680227 212835823 SLC1515X 00643169680036 212835829 SLC1510X 00643169680012 212835824 SLC2512X 00643169680203 212835832 SLC2012X 00643169680074 212835830 SLC2525X 00643169680234 212835825 SLC3520X 00643169680449 212835828 SLC3010X 00643169680319 212835831 SLC3530X 00643169680463 212835826 SLC4015X 00643169680531 212835822 SLC2515X 00643169680210 212846677 SLC2015X 00643169680081 212855147 SLC27515X 00643169680272 212846678 SLC2010X 00643169680067 212855152 SLC2012X 00643169680074 212846679 SLC3025X 00643169680357 212855146 SLC3015X 00643169680333 212855153 SLC22512X 00643169680142 212846676 SLC2512X 00643169680203 212846741 SLC2020X 00643169680098 212846740 SLC2510X 00643169680197 212855154 SLC1520X 00643169680043 212855151 SLC22515X 00643169680159 212855150 SLC3030X 00643169680364 212855155 SLC2012X 00643169680074 212855148 SLC2015X 00643169680081 212884040 SLC1510X 00643169680012 212884042 SLC2020X 00643169680098 212883779 SLC2515X 00643169680210 212883778 SLC2512X 00643169680203 212883776 SLC2012X 00643169680074 212904436 SLC2520X 00643169680227 212884041 SLC2015X 00643169680081 212904428 SLC2510X 00643169680197 212904437 SLC2020X 00643169680098 212904427 SLC2512X 00643169680203 212904431 SLC2515X 00643169680210 212904430 SLC2520X 00643169680227 212904435 SLC3515X 00643169680432 212904424 SLC3020X 00643169680340 212904433 SLC1512X 00643169680029 212904432 SLC1520X 00643169680043 212883777 SLC27512X 00643169680265 212904425 SLC4020X 00643169680548 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212931290 SLC22520X 00643169680166 212931099 SLC2530X 00643169680241 212938532 SLC22525X 00643169680173 212931289 SLC2525X 00643169680234 212938534 SLC22512X 00643169680142 212938535 SLC3006X 00643169680302 212938530 SLC3025X 00643169680357 212938537 SLC2020X 00643169680098 212948305 SLC2015X 00643169680081 212948306 SLC2012X 00643169680074 212948310 SLC2010X 00643169680067 212955580 SLC2520X 00643169680227 212948308 SLC2515X 00643169680210 212948312 SLC2030X 00643169680111 212948314 SLC2512X 00643169680203 212948315 SLC27512X 00643169680265 212948303 SLC22520X 00643169680166 212948307 SLC3015X 00643169680333 212948313 SLC22512X 00643169680142 212955581 SLC22510X 00643169680135 212955156 SLC22515X 00643169680159 212955157 SLC2520X 00643169680227 212955584 SLC2015X 00643169680081 212967871 SLC2015X 00643169680081 212955582 SLC2020X 00643169680098 212967867 SLC3020X 00643169680340 212948311 SLC27515X 00643169680272 212955158 SLC1515X 00643169680036 212948309 SLC1520X 00643169680043 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  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ESTONIA, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KOREA, LATVIA, LEBANON, LIECHTENSTEIN, LITHUANIA, MALAYSIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PAPUA NEW GUINEA, PHILIPPINES, POLAND, PORTUGAL, REUNION, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VIET NAM
  • 제품 설명
    Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
  • Manufacturer
    Medtronic Vascular Galway DBA Medtronic Ireland

Manufacturer

Medtronic Vascular Galway DBA Medtronic Ireland
  • 제조사 주소
    Medtronic Vascular Galway DBA Medtronic Ireland, Parkmore Business Park West, Galway Ireland
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA