MICROVENTION INC. — Class II: BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US
MicroVention Inc. has initiated a Class II recall for the BOBBY Balloon Guide Catheter due to an increased rate of balloon pinhole defects. The affected products include multiple reference numbers (BOB-895-CN, -EMEA, -EMEA-AL, -US, and MV-BGA01095) used for intravascular catheter guidance.
This recall affects MicroVention Inc., healthcare providers using the BOBBY Balloon Guide Catheter in peripheral and neurovascular systems, and internal quality and regulatory teams responsible for catheter manufacturing and distribution.
The identification of pinhole defects in a balloon guide catheter suggests potential compromises in the device's ability to maintain pressure or facilitate proper vessel guidance. For regulatory professionals, this indicates a failure in manufacturing quality or material integrity that necessitated an ongoing recall to mitigate patient risk during neurovascular procedures.
QA and Clinical teams should immediately verify inventory against the specified REF numbers (BOB-895 series) and MV-BGA01095. Regulatory departments should assess existing Post-Market Surveillance data for similar balloon integrity issues and ensure CAPA processes address the root cause of the pinhole defects.
Class II. Reason: Due to an increase rate of balloon pinhole defects.. 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.. Firm: MICROVENTION INC. (Aliso Viejo CA United States). Status: Ongoing.
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