Abbott StarClose SE Vascular Closure System Recall for Deployment Failure
Abbott Vascular is recalling the StarClose SE Vascular Closure System because the device may fail to deploy the clip.
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: The recall is classified as FDA Class II, and the hazard involves a functional failure of a medical device (failure to deploy) which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Abbott Vascular is recalling the StarClose SE Vascular Closure System, Part No. 14679-01 and 14679-02. The recall is being conducted because the device may exhibit difficulty or failure to deploy the StarClose SE Clip.
The recall involves 170,008 units total, with 83,029 units distributed in the United States. The product was distributed to Germany, Italy, Puerto Rico, Spain, Sweden, and Switzerland. The UDI for the product is 08717648079467 and the GMDN is 47411.
Healthcare providers should stop using the affected devices and contact Abbott Vascular for further instructions. Patients who have had this device implanted should contact their healthcare provider if they experience any issues.
The recalled product
- Product
- StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
- Manufacturer
- Abbott Vascular
Distribution
Distributed in 1 state:
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