Abbott Vascular Recalls MitraClip Clip Delivery System Due to Mandrel Fracture
Abbott Vascular is recalling the MitraClip Clip Delivery System because a mandrel fracture may prevent the clip from detaching during implantation.
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 involves a medical device where a mechanical failure (mandrel fracture) prevents the intended function (clip detachment) during a procedure. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' as no specific injuries or deaths are mentioned in the source text.
Plain-English summary
Abbott Vascular is recalling the MitraClip Clip Delivery System (product number MSK0101) because of reports of mandrel fractures. The affected devices contain a One-Way Actuator Knob. The recall involves 7,600 units total, with 2,300 units distributed in the United States.
The recall is due to cases where a user attempted to implant a MitraClip, but the clip could not be detached from the delivery system due to a mandrel fracture. The MitraClip System includes the Clip Delivery System and the Steerable Guide Catheter. The Clip Delivery System is used to advance and manipulate the implantable MitraClip device for positioning on the mitral valve leaflets.
The recall covers specific lot numbers, including 50811U1, 50811U2, and 50812U1, among others. The devices were distributed worldwide, including in the United States, Puerto Rico, and numerous international countries. Users should contact Abbott Vascular for further instructions regarding the affected devices.
The recalled product
- Product
- MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS)
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
Distribution
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