Class 2 Device Recall FRED Flow ReDirection Endoluminal Device

• Date Initiated by Firm: June 07, 2023
• Date Posted: July 27, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2238-2023
• Recall Event ID: 92580
• Product Classification: Intracranial aneurysm flow diverter - Product Code OUT
• Product: FRED 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 Contact: Terrence 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: Process control
• Action: On 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 Commerce: 474
• Distribution: Worldwide - 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 Cycle: TPLC 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.