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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to…"
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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