Abbott MitraClip XTR Clip Delivery System Recalled for Malfunction
Abbott Vascular is recalling the MitraClip XTR Clip Delivery System because clips may open or become nonfunctional during implantation, requiring additional surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device malfunction that has resulted in additional surgery and intervention, meeting the criteria for a Severe rating.
Plain-English summary
Abbott Vascular is recalling the Abbott MitraClip XTR Clip Delivery System (Part: CDS0601-XTR, UDI: 08717648226366). The recall covers all serial numbers of the sterile, prescription-only device. The product was distributed to facilities in 49 U.S. states, the District of Columbia, and numerous foreign countries including Australia, Canada, and the United Kingdom.
The recall was initiated due to reports that implantable mitral valve repair system clips unexpectedly opened and became nonfunctional. This malfunction resulted from unintended excessive force applied during the clip implantation process. The excessive force can also cause unexpected movement of the clip arms. The inability to close and remove the device has led to the need for surgery and additional medical intervention.
Healthcare providers and patients should contact Abbott Vascular for further instructions regarding the use of these devices. The source text does not specify a particular action for consumers other than the general context of a medical device recall.
The recalled product
- Product
- Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers.
Distribution
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