Events

FLAIR Endovascular Stent Graft 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Peripheral Vascular Inc 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
    72459
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0223-2016
  • 사례 시작날짜
    2015-10-19
  • 사례 출판 날짜
    2015-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141101
  • 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
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • 원인
    Bard peripheral vascular (bpv) is recalling the bard flair endovascular stent graft because of the harm associated with failure to deploy or deployment related issues that could occur during use.
  • 조치
    Bard sent an Urgent Medical Device Recall Notification letter dated October 19, 2015, to customers who received the Bard Flair Endovascular Stent Grant. The letter informs customers that the harm associated with failure to deploy or deployment related issues that could occur during use may pose an incremental risk to the already inherit risk associated with stent graft procedures. The letter also provides customers with the actions to be taken. Customers were instructed to call Bard Peripheral Vascular's (BPV) Recall Coordinator at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST). Customers were instructed to fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772.

Device

FLAIR Endovascular Stent Graft
  • 모델명 / 제조번호(시리얼번호)
    Product Code: FAF08070,  Lot No.  ANWJ3216  ANXD0762  ANXI2396  ANYG0316  ANWJ3217  ANXD1279  ANXI3475  ANYG0654  ANWK0056  ANXD1280  ANXJ1793  ANYG1630  ANWK0057  ANXD1641  ANXJ2700  ANYG3413 ANWK0058  ANXD1642  ANXK0641  ANYG3414 ANWK0567  ANXD1643  ANXK3033  ANYH0028 ANWK0568  ANXD1644  ANXL0612  ANYH0029 ANWK0569  ANXD2494  ANXL0947  ANYH0982 ANWK0570  ANXD2495  ANXL1451  ANYH0983 ANWK0571  ANXD2496  ANXL1752  ANYH2304 ANWK0572  ANXD2992  ANXL1865  ANYH3647 ANWK2441  ANXD2993  ANYA0042  ANYI2267 ANWK2442  ANXD2994  ANYA0050  ANYI2914 ANWK2443  ANXE0280  ANYA0933  ANYJ0077 ANWK2444  ANXE0281  ANYA1633  ANYJ1318 ANWK2445  ANXE0282  ANYA2052  ANYJ1833 ANWK3391  ANXE0652  ANYA2370  ANYJ2864 ANWK3809  ANXE0653  ANYA2531  ANYK0724 ANWK3810  ANXE0654  ANYB0456  ANYK1157 ANWL0501  ANXE0655  ANYB1022  ANYK2348 ANWL0502  ANXE1453  ANYB2410  ANYK3056 ANWL0507  ANXE2049  ANYB3171  ANZB1342 ANWL0508  ANXE2050  ANYB3172  ANZC0859 ANWL0509  ANXE3161  ANYB3509 ANXA0088  ANXF0165  ANYB3510 ANXA0089  ANXF0166  ANYC0062 ANXA0924  ANXF1325  ANYC2197 ANXA0925  ANXF1326  ANYD0186 ANXA3026  ANXF2393  ANYD0187 ANXB0438  ANXF2394  ANYD0725 ANXB0439  ANXF2395  ANYD1177 ANXB0440  ANXG0227  ANYD1906 ANXB3276  ANXG1407  ANYD2532 ANXB3277  ANXG2477  ANYD3370 ANXB3278  ANXH1052  ANYE0227 ANXB3279  ANXH1586  ANYE1280 ANXB4024  ANXH1587  ANYE2757 ANXB4025  ANXH2842  ANYE3276 ANXB4026  ANXH3098  ANYF0203 ANXC0523  ANXH3100  ANYF0243 ANXD0758  ANXI0375  ANYF2027 ANXD0759  ANXI1296  ANYF2028 ANXD0760  ANXI1298  ANYF2411 ANXD0761  ANXI2395  ANYF3184     Product Code: FAS08070 Lot No. ANWJ3097  ANXC2796  ANYA0036  ANYK2342 ANWJ3098  ANXC2797  ANYA0037  ANYK3044 ANWJ3099  ANXD0029  ANYA0939  ANZB1349 ANWK0580  ANXD0030  ANYA2054  ANZB1350 ANWK0581  ANXD0031  ANYA2678  ANZB1351 ANWK0582  ANXD0032  ANYA3222 ANWK0583  ANXD2812  ANYB0453 ANWK1097  ANXD4188  ANYB1024 ANWK1098  ANXD4189  ANYB2414 ANWK1099  ANXD4607  ANYB3174 ANWK1100  ANXE1146  ANYB3177 ANWK1101  ANXE1147  ANYB3178 ANWK2446  ANXE1465  ANYC0218 ANWK2447  ANXE1466  ANYC1998 ANWK3392  ANXE3173  ANYC2328 ANWK3393  ANXF0156  ANYD2752 ANWK3394  ANXF1333  ANYD3371 ANWK3570  ANXF2407  ANYE0228 ANWK3571  ANXF2408  ANYE1278 ANWK3572  ANXF2866  ANYE2516 ANWK3811  ANXG0229  ANYE3282 ANWK3812  ANXG1416  ANYF0204 ANWK4023  ANXG2513  ANYF0247 ANWK4024  ANXH1078  ANYF2025 ANWL0504  ANXH1589  ANYF2621 ANWL0505  ANXH3102  ANYF3189 ANWL0506  ANXI0389  ANYG1006 ANWL1086  ANXI1336  ANYG1939 ANXA0679  ANXI2405  ANYG2864 ANXB0898  ANXJ1254  ANYG3426 ANXB0899  ANXJ1795 ANYG3427 ANXB1372  ANXJ2068  ANYG3428 ANXB1373  ANXJ2709  ANYH0039 ANXB1374  ANXJ2710  ANYH3655 ANXB1584  ANXK0651  ANYI0669 ANXB1585  ANXK0652  ANYI0677 ANXB1586  ANXK1600  ANYI1452 ANXB3283  ANXK1601  ANYI2270 ANXB3284  ANXK2564  ANYJ0072 ANXB3285  ANXK3027  ANYJ0085 ANXC1568  ANXL0427  ANYJ1334 ANXC1569  ANXL1186  ANYJ1839 ANXC1871  ANXL1450  ANYJ2873 ANXC1872  ANXL1867  ANYK1155
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide in US
  • 제품 설명
    FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm || The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared configuration devices are approximately 4mm larger in diameter than the body section.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc