| | Class 2 Device Recall BOBBY Balloon Guide Catheter |  |
| Date Initiated by Firm | April 30, 2026 |
|---|
| Date Posted | August 07, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2912-2026 |
|---|
| Recall Event ID |
98909 |
| 510(K)Number | K193607 |
|---|
| Product Classification |
Catheter, percutaneous - Product Code DQY
|
| Product | 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. |
|---|
| Code Information |
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
|
| FEI Number |
3013556777
|
Recalling Firm/
Manufacturer |
MICROVENTION INC.
35 Enterprise
Aliso Viejo CA 92656
|
| For Additional Information Contact | Terrence Callahan
949-899-7194 |
|---|
Manufacturer Reason
for Recall | Due to an increase rate of balloon pinhole defects. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | On 04/30/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was mailed to customers informing them that due to an increased rate of balloon pinhole defects (inflation-related issues).
Customers are instructed to:
1. Immediately stop using and quarantine the affected BOBBY Balloon Guide Catheters
2. Reconcile, complete and return the "CUSTOMER ACKNOWLEDGEMENT FORM" via email to Terumo4118@sedgwick.com or FAX +1 877-650-7688 and return affected products.
3. Provide Recall Letter to any/all medical facilities to your organization has distributed recalled products to.
4. Return Product
-Return product through provided Ground Return Service or Return Service Label receipt provided in this recall notification and ship the products to Processing Center through the below contact.
Ship to Address
2670 Executive Drive Suite A
Indianapolis, IN 46241 USA
-Credit will be issued for customer purchased products upon return and verification of recall unit(s).
For Questions or further assistance - contact Sedgwick at +1 877-650-7686 or direct any questions to Terumo Neuro Sr. Director of Post Market Surveillance at +1 949-899-7194 Monday -Friday 8:00 a.m. to 5:00 p.m. (PST) or email recalls@microvention.com |
|---|
| Quantity in Commerce | 5500 devices |
|---|
| Distribution | 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = DQY
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