Abbott Vascular Cardiovascular Device Recalled for Leaks and Loose Connections
Abbott Vascular is recalling the 20/30 Priority Pack w/COPILOT device due to an increase in complaints of leaks and loose connections. The recall affects 131 lots distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II medical device recall involving leaks and loose connections in a cardiovascular device. No injuries or hospitalizations have been reported in the source material. As a risk-of-harm product with documented complaints but no reported injury, this qualifies as High severity.
Plain-English summary
Abbott Vascular is recalling the 20/30 Priority Pack w/COPILOT (Reference 1003327, WPL2122272-01) due to an increase in complaint trends for leaks and intermittent or loose connections. The recall involves 131 lots of the product.
The affected devices have been distributed nationwide throughout the United States, as well as internationally to multiple countries. Patients and healthcare facilities should contact Abbott Vascular for instructions on affected units.
If you have received one of the affected lots, consult with your healthcare provider regarding the appropriate next steps for your care and any replacement or discontinuation of use.
The recalled product
- Product
- 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 131
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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