Reported Aug 19, 2026 · Ongoing · Updated Aug 25, 2026

BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in…

Microvention Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MICROVENTION INC. · 35 Enterprise · Aliso Viejo, CA · 92656

Is this the product you have?

  • BOBBY Balloon Guide Catheter REFBOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems
Lot codes and dates
  • Catalog NumberBOB-895-CN
  • UDI codes(01)00842429111062(11)250819(17)280731(10)0001218734 (01)00842429111062(11)250822(17)280731(10)0001222844 (01)00842429111062(11)250825(17)280731(10)0001224137 (01)00842429111062(11)250828(17)280731(10)0001226522 (01)00842429111062(11)250910(17)280831(10)0001264372 (01)00842429111062(11)250911(17)280831(10)0001281308 (01)00842429111062(11)250917(17)280831(10)0001283704
  • Lot Numbers0001218734 0001222844 0001224137 0001226522 0001264372 0001281308 0001283704
  • Catalog NumberBOB-895-EMEA
  • UDI code(01)00842429108550(11)241108(17)271031(10)0000756596 (01)00842429108550(11)241109(17)271031(10)0000757384 (01)00842429108550(11)241118(17)271031(10)0000758945 (01)00842429108550(11)241120(17)271031(10)0000765270 (01)00842429108550(11)241121(17)271031(10)0000767660 (01)00842429108550(11)241126(17)271031(10)0000772588 (01)00842429108550(11)241202(17)271130(10)0000774885 (01)00842429108550(11)241128(17)271031(10)0000778089 (01)00842429108550(11)241204(17)271130(10)0000779647 (01)00842429108550(11)241207(17)271130(10)0000781240 (01)00842429108550(11)241210(17)271130(10)0000784041 (01)00842429108550(11)241210(17)271130(10)0000799436 (01)00842429108550(11)241213(17)271130(10)0000802183 (01)00842429108550(11)241210(17)271130(10)0000802619 (01)00842429108550(11)241214(17)271130(10)0000809792 (01)00842429108550(11)241217(17)271130(10)0000812812 (01)00842429108550(11)241217(17)271130(10)0000814498 (01)00842429108550(11)241220(17)271130(10)0000816560 (01)00842429108550(11)250108(17)271231(10)0000818876 (01)00842429108550(11)250110(17)271231(10)0000823404 (01)00842429108550(11)241217(17)271130(10)0000823532 (01)00842429108550(11)250113(17)271231(10)0000828250 (01)00842429108550(11)250115(17)271231(10)0000830529 (01)00842429108550(11)250118(17)271231(10)0000836906 (01)00842429108550(11)250118(17)271231(10)0000837785 (01)00842429108550(11)250118(17)271231(10)0000863256 (01)00842429108550(11)250123(17)271231(10)0000866698 (01)00842429108550(11)250124(17)271231(10)0000874138 (01)00842429108550(11)250125(17)271231(10)0000875976 (01)00842429108550(11)250129(17)271231(10)0000906381 (01)00842429108550(11)250131(17)271231(10)0000912667 (01)00842429108550(11)250204(17)280131(10)0000915955 (01)00842429108550(11)250203(17)280131(10)0000919813 (01)00842429108550(11)250205(17)280131(10)0000922930 (01)00842429108550(11)250206(17)280131(10)0000927345 (01)00842429108550(11)250207(17)280131(10)0000930383 (01)00842429108550(11)250212(17)280131(10)0000937458 (01)00842429108550(11)250210(17)280131(10)0000945855 (01)00842429108550(11)250220(17)280131(10)0000976589
  • Lot Numbers
    • 0000756596
    • 0000784041
    • 0000823532
    • 0000912667
    • 0000757384
    • 0000799436
    • 0000828250
    • 0000915955
    • 0000758945
    • 0000802183
    • 0000830529
    • 0000919813
    • 0000765270
    • 0000802619
    • 0000836906
    • 0000922930
    • 0000767660
    • 0000809792
    • 0000837785
    • 0000927345
    • 0000772588
    • 0000812812
    • 0000863256
    • 0000930383
    • 0000774885
    • 0000814498
    • 0000866698
    • 0000937458
    • 0000778089
    • 0000816560
    • 0000874138
    • 0000945855
    • 0000779647
    • 0000818876
    • 0000875976
    • 0000976589
    • 0000781240
    • 0000823404
    • 0000906381
  • Catalog NumberBOB-895-EMEA-AL
  • UDI codes(01)00842429118511(11)250213(17)280131(10)0000985070 (01)00842429118511(11)250217(17)280131(10)0000991168 (01)00842429118511(11)250219(17)280131(10)0000992810 (01)00842429118511(11)250222(17)280131(10)0000993790 (01)00842429118511(11)250225(17)280131(10)0000994829 (01)00842429118511(11)250228(17)280131(10)0000995565 (01)00842429118511(11)250303(17)280229(10)0000996450 (01)00842429118511(11)250305(17)280229(10)0001015817 (01)00842429118511(11)250307(17)280229(10)0001016002 (01)00842429118511(11)250310(17)280229(10)0001018992 (01)00842429118511(11)250321(17)280229(10)0001021878 (01)00842429118511(11)250311(17)280229(10)0001023107 (01)00842429118511(11)250313(17)280229(10)0001025449 (01)00842429118511(11)250319(17)280229(10)0001028255 (01)00842429118511(11)250324(17)280229(10)0001029974 (01)00842429118511(11)250327(17)280229(10)0001031633 (01)00842429118511(11)250415(17)280331(10)0001053417 (01)00842429118511(11)250416(17)280331(10)0001055173 (01)00842429118511(11)250514(17)280430(10)0001056470 (01)00842429118511(11)250423(17)280331(10)0001060464 (01)00842429118511(11)250425(17)280331(10)0001061678 (01)00842429118511(11)250426(17)280331(10)0001062354 (01)00842429118511(11)250502(17)280430(10)0001069356 (01)00842429118511(11)250505(17)280430(10)0001071207 (01)00842429118511(11)250506(17)280430(10)0001072898 (01)00842429118511(11)250508(17)280430(10)0001074123 (01)00842429118511(11)250521(17)280430(10)0001083156 (01)00842429118511(11)250612(17)280531(10)0001085850 (01)00842429118511(11)250522(17)280430(10)0001093696 (01)00842429118511(11)250527(17)280430(10)0001101233 (01)00842429118511(11)250528(17)280430(10)0001103095 (01)00842429118511(11)250529(17)280430(10)0001104602 (01)00842429118511(11)250604(17)280531(10)0001108650 (01)00842429118511(11)250605(17)280531(10)0001110938 (01)00842429118511(11)250609(17)280531(10)0001112366 (01)00842429118511(11)250610(17)280531(10)0001113474 (01)00842429118511(11)250612(17)280531(10)0001115761 (01)00842429118511(11)250613(17)280531(10)0001117185 (01)00842429118511(11)250616(17)280531(10)0001118973 (01)00842429118511(11)250617(17)280531(10)0001120771 (01)00842429118511(11)250619(17)280531(10)0001121934 (01)00842429118511(11)250620(17)280531(10)0001123077 (01)00842429118511(11)250623(17)280531(10)0001125524 (01)00842429118511(11)250625(17)280531(10)0001128348 (01)00842429118511(11)250626(17)280531(10)0001136555 (01)00842429118511(11)250703(17)280630(10)0001144745 (01)00842429118511(11)250702(17)280630(10)0001146471 (01)00842429118511(11)250707(17)280630(10)0001147975 (01)00842429118511(11)250716(17)280630(10)0001158399 (01)00842429118511(11)250718(17)280630(10)0001171840 (01)00842429118511(11)250721(17)280630(10)0001173474 (01)00842429118511(11)250729(17)280630(10)0001174976 (01)00842429118511(11)250730(17)280630(10)0001178541 (01)00842429118511(11)250731(17)280630(10)0001197582 (01)00842429118511(11)250730(17)280630(10)0001202766 (01)00842429118511(11)250730(17)280630(10)0001210548
  • Lor Numbers
    • 0000985070
    • 0001031633
    • 0001101233
    • 0001136555
    • 0000991168
    • 0001053417
    • 0001103095
    • 0001144745
    • 0000992810
    • 0001055173
    • 0001104602
    • 0001146471
    • 0000993790
    • 0001056470
    • 0001108650
    • 0001147975
    • 0000994829
    • 0001060464
    • 0001110938
    • 0001158399
    • 0000995565
    • 0001061678
    • 0001112366
    • 0001171840
    • 0000996450
    • 0001062354
    • 0001113474
    • 0001173474
    • 0001015817
    • 0001068354
    • 0001115761
    • 0001174976
    • 0001016002
    • 0001069356
    • 0001117185
    • 0001176501
    • 0001018992
    • 0001071207
    • 0001118973
    • 0001178541
    • 0001021878
    • 0001072898
    • 0001120771
    • 0001197582
    • 0001023107
    • 0001074123
    • 0001121934
    • 0001202766
    • 0001025449
    • 0001083156
    • 0001123077
    • 0001210548
    • 0001028255
    • 0001085850
    • 0001125524
    • 0001029974
    • 0001093696
    • 0001128348
  • Catalog NumberBOB-895-US
  • UDI codes(01)00842429108543(11)250513(17)280430(10)0001079888 (01)00842429108543(11)250520(17)280430(10)0001081226 (01)00842429108543(11)250628(17)280531(10)0001141186 (01)00842429108543(11)250630(17)280531(10)0001173179 (01)00842429108543(11)250909(17)280831(10)0001262241 (01)00842429108543(11)251110(17)281031(10)0001437101 (01)00842429108543(11)251112(17)281031(10)0001438674 (01)00842429108543(11)251113(17)281031(10)0001441913 (01)00842429108543(11)251114(17)281031(10)0001443802 (01)00842429108543(11)251117(17)281031(10)0001446069 (01)00842429108543(11)251120(17)281031(10)0001453708
  • Lot Numbers
    • 0001079888
    • 0001081226
    • 0001141186
    • 0001173179
    • 0001262241
    • 0001437101
    • 0001438674
    • 0001441913
    • 0001443802
    • 0001446069
    • 0001453708
  • Catalog NumberMV-BGA01095
  • UDI codes(01)04987892126550(11)250328(17)280229(10)0001040227 (01)04987892126550(11)250401(17)280331(10)0001042037 (01)04987892126550(11)250402(17)280331(10)0001044937 (01)04987892126550(11)250404(17)280331(10)0001046984 (01)04987892126550(11)250405(17)280331(10)0001047845 (01)04987892126550(11)250404(17)280331(10)0001049680 (01)04987892126550(11)250410(17)280331(10)0001051771 (01)04987892126550(11)250428(17)280331(10)0001065613 (01)04987892126550(11)250509(17)280430(10)0001076001 (01)04987892126550(11)250512(17)280430(10)0001078798 (01)04987892126550(11)250523(17)280430(10)0001097321 (01)04987892126550(11)250602(17)280531(10)0001105939 (01)04987892126550(11)250603(17)280531(10)0001107168 (01)04987892126550(11)250630(17)280531(10)0001141182 (01)04987892126550(11)250708(17)280630(10)0001152231 (01)04987892126550(11)250729(17)280630(10)0001185056 (01)04987892126550(11)250827(17)280731(10)0001225126 (01)04987892126550(11)250829(17)280731(10)0001246712 (01)04987892126550(11)250903(17)280831(10)0001252741 (01)04987892126550(11)251022(17)280930(10)0001266651 (01)04987892126550(11)250912(17)280831(10)0001269171 (01)04987892126550(11)250918(17)280831(10)0001287190 (01)04987892126550(11)250925(17)280831(10)0001289538 (01)04987892126550(11)250925(17)280831(10)0001292699 (01)04987892126550(11)250926(17)280831(10)0001294020 (01)04987892126550(11)251018(17)280930(10)0001313654 (01)04987892126550(11)251018(17)280930(10)0001324855 (01)04987892126550(11)251006(17)280930(10)0001327705 (01)04987892126550(11)251010(17)280930(10)0001338930 (01)04987892126550(11)251013(17)280930(10)0001340374 (01)04987892126550(11)251018(17)280930(10)0001354479 (01)04987892126550(11)251023(17)280930(10)0001355468 (01)04987892126550(11)251027(17)280930(10)0001358653 (01)04987892126550(11)251028(17)280930(10)0001368184 (01)04987892126550(11)251028(17)280930(10)0001372365 (01)04987892126550(11)251030(17)280930(10)0001384037 (01)04987892126550(11)251118(17)281031(10)0001447547 (01)04987892126550(11)251126(17)281031(10)0001456760 (01)04987892126550(11)251126(17)281031(10)0001458008 (01)04987892126550(11)251127(17)281031(10)0001461756 (01)04987892126550(11)251202(17)281130(10)0001464579 (01)04987892126550(11)251203(17)281130(10)0001466946 (01)04987892126550(11)251205(17)281130(10)0001467787 (01)04987892126550(11)251208(17)281130(10)0001467789 (01)04987892126550(11)251209(17)281130(10)0001470337 (01)04987892126550(11)251216(17)281130(10)0001485515
  • Lot Numbers
    • 0001040227
    • 0001107168
    • 0001292699
    • 0001384037
    • 0001042037
    • 0001141182
    • 0001294020
    • 0001447547
    • 0001044937
    • 0001152231
    • 0001313654
    • 0001456760
    • 0001046984
    • 0001154356
    • 0001324855
    • 0001458008
    • 0001047845
    • 0001185056
    • 0001327705
    • 0001461756
    • 0001049680
    • 0001225126
    • 0001338930
    • 0001464579
    • 0001051771
    • 0001246712
    • 0001340374
    • 0001466946
    • 0001065613
    • 0001252741
    • 0001354479
    • 0001467787
    • 0001076001
    • 0001266651
    • 0001355468
    • 0001467789
    • 0001078798
    • 0001269171
    • 0001358653
    • 0001470337
    • 0001097321
    • 0001287190
    • 0001368184
    • 0001485515
    • 0001105939
    • 0001289538
    • 0001372365
Amount recalled
5500 devices

Where it was sold

Why it was recalled

Due to an increase rate of balloon pinhole defects.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Other recalls from Microvention Inc.

12 in total.

Where it was distributed

All recall categories · Browse the whole archive

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 2:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.