Abbott INDEFLATOR Plus 30 Device Recalled for Leaks and Connection Faults
Abbott Vascular is recalling INDEFLATOR Plus 30 balloon inflators due to increasing complaints of leaks and intermittent loose connections that could affect device function during medical procedures.
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: Class II medical device with documented complaint trend of functional defects (leaks and loose connections) that could compromise safe operation during invasive cardiac procedures. No reported injuries or deaths. Risk of harm is evident from the device's critical cardiac use context, but absence of reported adverse events limits severity to High per rubric.
Plain-English summary
Abbott Vascular is recalling INDEFLATOR Plus 30 devices (model REF 1000183) due to an increase in complaint reports of leaks and intermittent or loose connections. These are balloon inflation devices used during cardiovascular interventional procedures.
The recall affects six specific product lots distributed nationwide throughout all U.S. states and the District of Columbia, as well as internationally to more than 25 countries including Canada, Western Europe, Asia-Pacific, and Latin America.
Healthcare facilities and individuals who have received or may have these devices should contact Abbott Vascular immediately for instructions on device replacement and safe handling of the affected units during any active procedures.
The recalled product
- Product
- INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
- Manufacturer
- Abbott Vascular
- Hazard
- Affected units
- 6
Distribution
Part of a larger recall action
This product is one of 5 recalled by Abbott Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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