CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report
Bobby Balloon Guide Catheter recalled by Microvention
Microvention is recalling Bobby Balloon Guide Catheter, distributed nationwide in the US. The recall was initiated on 30 Apr 2026 and the FDA has classified it as Class II.
Check your package
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-2912-2026
- FDA event ID
- 98909
- Recalling firm
- Microvention, Aliso Viejo, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2026
- FDA classified
- 7 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 30 Apr 2026 | Recall initiated by company | |
| 7 Aug 2026 | Classified by FDA | +99 days |
| 19 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to an increase rate of balloon pinhole defects.
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
BOBBY Balloon Guide Catheter REF: BOB-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.
Where it was distributed
Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Ukraine, and United Kingdom. Asia - China, Japan, Jordan, New Zealand, South Korea, and United Arab Emirates.
Nationwide AlabamaArkansasArizonaCaliforniaFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMichiganMinnesotaMissouriMontanaNorth CarolinaNew HampshireNew MexicoNew YorkOhio
Questions about this recall
Why was it recalled?
Due to an increase rate of balloon pinhole defects.
Which lots are affected?
Catalog Number: BOB-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 Numbers: 0001218734 0001222844 0001224137 0001226522 0001264372 0001281308 0001283704 Catalog Number: BOB-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 Number: BOB-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 Number: BOB-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 Number: MV-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
Where was it sold?
Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Ukraine, and United Kingdom. Asia - China, Japan, Jordan, New Zealand, South Korea, and United Arab Emirates.
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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