MitraClip Clip Delivery System Recalled for Locking Malfunctions
Abbott Vascular is recalling MitraClip Clip Delivery System devices due to observed increases in clip locking malfunctions that can lead to recurrence of mitral regurgitation, device embolization, or tissue injury.
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 FDA Class II recall involves a cardiac device with observed malfunctions that could lead to serious patient harm including device embolization and tissue injury. However, without reported hospitalizations or deaths, it meets the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Abbott Vascular is recalling multiple variants of the MitraClip Clip Delivery System, medical devices used during cardiac procedures to treat mitral valve regurgitation. Approximately 18,042 units have been distributed worldwide, including throughout the United States.
The recall was initiated because of an observed increase in clip locking malfunctions. Specifically, users have reported issues with establishing the final arm angle and maintaining the clip in an open position while locked. The contributing causes are believed to include material properties of the clip locking component and certain use conditions.
When the clip fails to lock properly during a procedure, the intervention may be unsuccessful. This can result in recurrence of severe mitral regurgitation, device embolization (where the device breaks free and travels through blood vessels), or tissue injury. Healthcare providers and patients should be aware of these potential complications.
The recalled product
- Product
- Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW…
- Manufacturer
- Abbott Vascular
- Affected units
- 18,042
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 (6)
- Part/UDI: CDS0601-XTR/08717648226366
- CDS0701-NT/08717648230943
- CDS0701-NTW/08717648230967
- CDS0701-XT/08717648230981
- CDS0701-XTW/08717648231001
- All lots.
Distribution
Part of a larger recall action
This product is one of 3 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.
See all 3 products in this recall →Related recalls
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