BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating

FDA device recall Z-2912-2026 · posted 2026-08-07 · Open, Classified

Recall details

Recalling firm

MICROVENTION INC.

Reason for recall

Due to an increase rate of balloon pinhole defects.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DQY

Quantity affected

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,

Date initiated

2026-04-30

Date posted

2026-08-07

Location

Aliso Viejo, CA

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