Recall Z-2912-2026 ยท DQY Catheter, Percutaneous
MICROVENTION INC.
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.
| Date | Aug 7, 2026 (initiated Apr 30, 2026) |
| Status | Open, Classified |
| Reason | Due to an increase rate of balloon pinhole defects. |
| Root cause | Under Investigation by firm |
| Action | 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 produc |
| Quantity | 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, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193607 | BOBBY Balloon Guide Catheter MicroVention, Inc., Jul 21, 2020 |