Microvention recalls Bobby Balloon Guide Catheters with serial numbers BOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, and MV-BGA01095 due to increased balloon pinhole defects.
Due to an increase rate of balloon pinhole defects.
Microvention is recalling certain Bobby Balloon Guide Catheters because they have a higher rate of balloon pinhole defects. This could lead to potential complications during medical procedures.
The catheter balloons may develop pinholes, which could allow blood to leak into the bloodstream during medical procedures. This might cause complications like infections or bleeding.
Healthcare professionals using Microvention's Bobby Balloon Guide Catheters with specific model numbers and lot codes listed in the recall notice. Patients using these catheters during procedures are at risk if the device fails.
Check for model numbers: BOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, or MV-BGA01095. Also, verify the lot numbers listed in the recall notice.
Look for the model numbers and lot numbers listed in the recall notice to determine if your catheter is affected.
Microvention is recalling certain Bobby Balloon Guide Catheters due to an increased rate of balloon pinhole defects.
Check the model numbers (BOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, or MV-BGA01095) and lot numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact Microvention directly for guidance.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-2912-2026 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-2912-2026 from Microvention. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
