Microvention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
Microvention Inc. is recalling 5,500 Bobby Balloon Guide Catheters worldwide due to an increased rate of balloon pinhole defects.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Microvention Inc. is voluntarily recalling 5,500 units of the Bobby Balloon Guide Catheter. The recall is being conducted due to an increased rate of balloon pinhole defects in the devices.
The affected devices are used to facilitate the insertion and guidance of an intravascular catheter into selected blood vessels in the peripheral and neurovascular systems. The recall covers multiple catalog numbers, including BOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, and MV-BGA01095.
Distribution was worldwide, including nationwide distribution in the United States and specific countries in Europe, Asia, and South Africa. The source text does not specify the corrective action consumers or healthcare providers should take, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- 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.
- Manufacturer
- MICROVENTION INC.
- Hazard
- Affected units
- 5,500
Distribution
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