Z-2238-2023Class II

FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA...

Name: Z-2238-2023 FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA...
Creator: Microvention Inc.
Published: 2023-06-07
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2023-06-07 / Open, Classified / root cause: manufacturing process

FDA source

MICROVENTION INC. began a recall of FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA... on 2023-06-07. FDA classified it as Class II and gives the reason as "Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2238-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-07
Posted: 2023-07-27
Recalling firm: Terumo Cardiovascular Systems Corporation
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
Product code: OUT Intracranial Aneurysm Flow Diverter
Reason for recall: Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2238-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2238-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-27

Product code OUT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)