CLASS II ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report

FRED Flow Re-Direction Endoluminal Device recalled by Microvention

Microvention is recalling FRED Flow Re-Direction Endoluminal Device, distributed nationwide in the US. The recall was initiated on 7 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevices 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 recalled474

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2238-2023
FDA event ID: 92580
Recalling firm: Microvention, Aliso Viejo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Jun 2023
FDA classified: 27 Jul 2023
Reported: 2 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

7 Jun 2023	Recall initiated by company
27 Jul 2023	Classified by FDA	+50 days
2 Aug 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama Arizona California Delaware Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Missouri Mississippi North Carolina New Jersey New York

Questions about this recall

Why was it recalled?

Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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