MICROVENTION BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL recall — FDA Z-2912-2026
Due to an increase rate of balloon pinhole defects.
Overview of recall records associated with Microvention, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 31, Class III: 3.
Due to an increase rate of balloon pinhole defects.
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased…
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to…
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted…
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into…
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
The devices may be missing the implant coil.
This page summarizes recall records in which the official source identifies Microvention, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.