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U.S. Department of Health and Human Services

Class 2 Device Recall FRED Flow ReDirection Endoluminal Device

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 Class 2 Device Recall FRED Flow ReDirection Endoluminal Devicesee related information
Date Initiated by FirmJune 07, 2023
Date PostedJuly 27, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2238-2023
Recall Event ID 92580
Product Classification Intracranial aneurysm flow diverter - Product Code OUT
ProductFRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508, FRED4508-PMA, FRED4513-PMA, FRED4518-PMA, FRED4528, FRED4528-PMA, FRED4539, FRED4539-CA, FRED4539-PMA, FRED5009, FRED5009-PMA, FRED5014-PMA, FRED5019-PMA, FRED5029, FRED5029-CA, FRED5029-PMA, FRED5514-CA, FRED5514-PMA, FRED5526-CA, FRED5526-PMA, MV-F351127, MV-F352427, MV-F401227, MV-F401727, MV-F451327, MV-F500927, MV-F501427, MV-F501927, MV-F552627
Code Information Devices manufactured between June 1, 2020, and September 29, 2020. REF/UDI/Lot: FRED3507-PMA/00842429106655/200703556, 20070654P, 20072255L, 20072255N, 20073056A, 20073056B, 200807599, 20081453X, 20082656F, 20082656G, 20082852H, 20083152E; FRED3511/20073054C, 20091654Z, 200917511; FRED3511-PMA/00842429106662/20070754K, 200716562, 200721573, 20072252J, 20072255P, 20072255Q, 20080851B, 20082656H, 20082656J, 20090152R; FRED3516-CA/20081154U; FRED3516-PMA/00842429106679/20070654Q, 200716563, 20072158F, 200731555, 20080354B, 20081154W; FRED3524/00811425020982/200702553, 200706563, 20071557U, 200720563, 20081955R, 20091654T, 20091857N, 20092357X; FRED3524-CA/200924555; FRED3524-PMA/00842429106686/200716564, 200716565, 20072255U, 20072255V, 2007225AZ, 20073056C, 20073056Q, 20073056R, 20080459V, 20080558E, 20080853W, 2008115AC, 20081255W, 20081354Q, 200909564, 200909565, 200909664, 20091558Z, 20092156J, 20092166J; FRED3536-CA/20092859F, 20092955K; FRED3536-PMA/20070654R, 20071556Z, 200716566, 20072255W, 20072255X, 20080558G, 20081255X, 20090955W, 200915547, 200915591, 200916569, 200923539, 20092356W, 20092356X, 20092957Y; FRED4007-PMA/00842429106709/20072255Y, 20072255Z, 20072455H, 20073056Y, 20073056Z, 200730571, 20080558H, 20080558K, 20090255J, 20091555N; FRED4012-CA/20081255H; FRED4012-PMA/00842429106723/200703557, 200703575, 200730572, 200730573, 200806569, 20081957L, 20082656Q, 20092356Y, 20092356Z, 200929581; FRED4017-PMA/00842429106730/20070154P, 200702514, 200703558, 200730575, 200806589, 200812562, 20081354G, 200813554, 200901548, 200902548, 2009085AT, 2009095B2; FRED4026/20070754G, 20080556Z, 20081356V, 20081955T, 200928541M; FRED4026-PMA/00842429106747/20070452Q, 200730577, 20081453Y, 200923571, 200923572, 200927516, 200928532, 200928541, 20093055H, 20093065H; FRED4038-PMA/00842429106754/200722561, 200722562, 20082656R, 20083152F, 200831594, 200901595, 200902545, 200902546, 20090759V, 200909569, 20091656E, 20091659G, 2009175A1, 2009175A3, 20091953C, 20091953E, 20091953F, 20092156N, 20092156R, 2009225AX, 200923573, 200923574, 20092459J, 20092469J, 20092557J, 200926535, 20092956H, 20093056X, 200930586; FRED4508/00811425021057/200805571, 20080851A, 20081154R; FRED4508-PMA/00842429106761/200703559, 200722563, 200722564, 20073057C, 20073057E, 20082656V, 20082656W, 200831598, 2009015A1, 20091555Q; FRED4513-PMA/00842429106778/200702569, 20070256A, 200713549, 20073057F, 20073057G, 200807546, 200902562, 200923575, 200923576; FRED4518-PMA/00842429106785/200702597, 20070355A, 200721576, 20073057J, 20080851E, 200808535; FRED4528/20070653Z, 200716556, 20072258F; FRED4528-PMA/200902564, 200908524; FRED4539/200706541, 20071553E, 20092955L; FRED4539-CA/20092853Z, 20092957K; FRED4539-PMA/00842429106808/200722565, 200722566, 20080558Q, 20080558R, 200812568, 200812569, 20081957V, 20081957W, 20082656X, 20082656Y, 20082656Z, 20082954E, 20083152G, 20083154W, 200901594, 200902565, 200902566, 2009025AQ, 2009025CB, 200903594, 20090451X, 20090956C, 20091055L, 20091253U, 20091656F, 20091659F, 20091751N, 20091952B, 20091953A, 200922537, 200922584, 200922585, 200922684, 200923577, 200923578, 200923678, 20092553C, 20092553E, 200925571, 20092557H, 20092563C, 200926522, 20092652C, 20092858U, 20092868U, 200929583; FRED5009/20081254Z, 20081355F; FRED5009-PMA/00842429106815/20070256B, 200703574, 200722567, 20073057P, 20073057Q, 20073057R, 20080457X, 20080558T, 20080558U, 20081258J, 200902567; FRED5014-PMA/00842429106822/20070256E, 20070256F, 200706571, 20071553L, 20071651L, 200717545, 2007225B1, 200811596, 20082559G; FRED5019-PMA/00842429106839/20070754L, 200721577, 20073057T, 200826571, 20090152T, 200901593, 2009015A6, 2009025BZ; FRED5029/20073054E, 200812551; FRED5029-CA/20091655V, 20091665V, 20092156Q, 20092166Q; FRED5029-PMA/00842429106846/20070256J, 20070256K, 20070256L, 20070452X, 200713556, 2007135A3, 20081957Y, 200922539, 200923579, 20092357A, 200928542, 200929584; FRED5514-CA/20071655K, 2009085AU, 200922536; FRED5514-PMA/00842429106853/20070256N, 20070452Y, 20072258C, 20081957Z, 200819581, 20082655Z, 200826561, 200826661, 20082758U, 20090154H, 200902568, 200904552, 20090457F, 20090956G; FRED5526-CA/20092957L; FRED5526-PMA/00842429106860/20070254L, 20070256P, 20070256Q, 20070256R, 20071557R, 200819583, 200826573, 20092156L, 20092357B, 200929585; MV-F351127/20081358X, 20090954X, 20090956K; MV-F352427/200722M5U, 200730M6Q; MV-F401227/200730M72, 200806M69, 200819M7L, 200826M6Q, 200923M6Z; MV-F401727/200701M4P, 200901M48, 200909MB2; MV-F451327/200702M69, 200702M6A, 200713M49, 200730M7F, 200730M7G, 200807M46, 200923M75; MV-F500927/20090956N; MV-F501427/200702M6F, 200706M71, 200715M3L, 200716M1L, 200811M96; MV-F501927/200730M7T; MV-F552627/200702M4L, 200702M6Q
Recalling Firm/
Manufacturer
MICROVENTION INC.
35 Enterprise
Aliso Viejo CA 92656
For Additional Information ContactTerrence Callahan
949-899-7194
Manufacturer Reason
for Recall
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
FDA Determined
Cause 2
Process control
ActionOn 6/7/23 recall notices were emailed to customers who were asked to stop use, quarantine, and return affected devices. Follow-up notices were mailed to customers on 6/16/23. Customers were asked to share the notice with all device users within the facility and network and share the notice with any organization where potentially affected devices have been transferred. In addition, customers were asked to complete and return the customer acknowledgement form. Inquiries can be directed to customer service at 800-990-8368.
Quantity in Commerce474
DistributionWorldwide - US Nationwide distribution including in the states of AZ, NY, FL, CA, PA, SC, TX, IL, MA, NJ, VA, GA, OH, IN, MI, KY, AL, MO, SD, LA, WA, HI, KS, MD, OK, DE, NC, MS and the countries of Taiwan, Chile, India, South Korea, Malaysia, Canada, France, Morocco, Belgium, Spain, Turkey, Poland, Russian Federation, Czech Republic, Slovenia, Germany, United Kingdom, El Salvador, United Arab Emirates, Bulgaria, Portugal, Brazil, Iran, Malta, Vietnam, South Africa, Jordan, Japan, Uruguay.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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