Data Foundry

Medical device recalls 2026

BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA… — Class II medical device recall Z-2912-2026

Ongoing recall by MICROVENTION INC., reported 2026-08-19, distributed nationwide. Due to an increase rate of balloon pinhole defects.

Recall numberZ-2912-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMICROVENTION INC., Aliso Viejo, CA, United States
Recall initiated2026-04-30
Classified2026-08-07
Reported by FDA2026-08-19
DistributedNationwide (US)
Countries outside the USAE, AT, BE, CH, CN, DE, DK, ES, FI, FR, GB, GR, IE, IS, IT, JO, JP, KR, LT, NL, NO, NZ, PL, RO, SE, SI, UA, ZA
Quantity5,500 devices
UPC / GTIN / UDI-DI00842429108543, 00842429108550, 00842429111062, 00842429118511, 04987892126550
Lot numbers0000756596, 0000757384, 0000758945, 0000765270, 0000767660, 0000772588, 0000774885, 0000778089, 0000779647, 0000781240, 0000784041, 0000799436, 0000802183, 0000802619, 0000809792, 0000812812, 0000814498, 0000816560, 0000818876, 0000823404, 0000823532, 0000828250, 0000830529, 0000836906, 0000837785, 0000863256, 0000866698, 0000874138, 0000875976, 0000906381, 0000912667, 0000915955, 0000919813, 0000922930, 0000927345, 0000930383, 0000937458, 0000945855, 0000976589, 0001040227 and 64 more
Model numbersBOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, MV-BGA01095

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.

Reason for recall

Due to an increase rate of balloon pinhole defects.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2912-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.