FDA Recalls Abbott Vascular Priority Pack Accessory Kits for Leak and Connection Issues
Abbott Vascular is recalling 23 lots of Priority Pack accessory kits and packs due to reports of leaks and loose connections in the devices.
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: FDA Class II recall for a medical device with potential device malfunction risk from leaks and loose connections. No illnesses or injuries reported, but the potential for patient harm from connection failure warrants a High classification.
Plain-English summary
Abbott Vascular is recalling 23 lots of its 20/30 Priority Pack Accessory Kit and 20/30 Priority Pack products due to an increasing trend of complaints involving leaks and loose connections. The affected product lots include Part Number 1000186 (Device Identifier 08717648013614) and Part Number 1000186-115 (Device Identifier 08717648015274).
These devices were distributed nationwide across all U.S. states and territories, as well as internationally to countries including Canada, Mexico, the United Kingdom, France, Australia, Germany, Japan, and others.
The recall was initiated in response to reports of leaks and intermittent or loose connections affecting the devices. No specific information about reported illnesses or injuries has been made available in this recall notice.
Healthcare providers and patients who have received these devices should contact Abbott Vascular or their healthcare provider for guidance on replacement or alternative options.
The recalled product
- Product
- 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
- Manufacturer
- Abbott Vascular
- Hazard
- device-leak
- loose-connection
Distribution
Distributed nationwide across the United States.
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