FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352
Summary
The FDA issued a Class II for FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511 by MICROVENTION INC.. Reason: Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended..
Details
Source
Device Recall
External ID
Z-2238-2023
Action Date
2023-08-02
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 474
Reason for Recall
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-07
Company
Aliso Viejo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MICROVENTION INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MICROVENTION INC. have FDA actions?
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2238-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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