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BOBBY Balloon Guide Catheter
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MEDICAL DEVICE RECALLMODERATE

BOBBY Balloon Guide Catheter

MicroVention recalls BOBBY Balloon Guide Catheters due to increased balloon pinhole defects.

What to do

Do not use the affected BOBBY Balloon Guide Catheter. Contact MicroVention for instructions on returning the device and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2912-2026
Agency
FDA
Firm
MICROVENTION INC.
Recall ID
98909
Status
ONGOING

Recall at a glance

Quantity recalled
5500 devices

Why it was recalled

MicroVention is recalling the BOBBY Balloon Guide Catheter due to an increased rate of balloon pinhole defects, which may cause the balloon to fail to inflate or deflate properly during procedures. The affected catheters are used to facilitate the insertion and guidance of an intravascular catheter into selected blood vessels in the peripheral and neurovascular systems.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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.

Lot code
0001218734, 0001222844, 0001224137, 0001226522, 0001264372, 0001281308, 0001283704, 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 (+64 more, see the official notice)
UDI-DI
00842429111062, 0001218734, 00842429111062, 0001222844, 00842429111062, 0001224137, 00842429111062, 0001226522, 00842429111062, 0001264372, 00842429111062, 0001281308, 00842429111062, 0001283704, 0001218734, 0001222844, 0001224137, 0001226522, 0001264372, 0001281308

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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All recalls from MICROVENTION INC.

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Editorial summary by Recall Canary · summary updated 2026-08-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification