MicroVention BOBBY catheter recalled for balloon pinhole defects
MicroVention is recalling certain BOBBY Balloon Guide Catheters because the balloons may develop pinhole defects, which occur at an increased rate. The catheter is used by health care providers to guide a catheter into blood vessels during peripheral and neurovascular procedures. The FDA has classified the recall as Class II, and no injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- If you work in a health care facility, check whether it has any BOBBY catheters with the listed catalog and lot numbers.
- If you have an upcoming procedure, ask your care team whether the device used is affected by this recall.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 5500 devices
- Illnesses reported
- None reported
- Manufactured in
- 35 Enterprise, Aliso Viejo, CA, United States
- Classification
- Class II
- Recall number
- Z-2912-2026
In the FDA's words
- Description
- 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. Due to an increase rate of balloon pinhole defects. 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)
- Hazard
- Due to an increase rate of balloon pinhole defects.