MitraClip G4 and TriClip G4 Cardiac Devices Recalled for Clip Locking Malfunction
Abbott has recalled MitraClip G4 and TriClip G4 cardiac repair devices due to clip locking malfunctions that may prevent proper device deployment. These malfunctions could lead to failed procedures and serious complications including device embolization.
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: Class II medical device recall with documented clip locking malfunctions that could lead to serious patient complications including device embolization and tissue injury. No cases of actual harm or illness are reported in the source.
Plain-English summary
Abbott Vascular has recalled certain MitraClip G4 and TriClip G4 cardiac repair devices due to increased clip locking malfunctions. These devices are used in cardiac procedures to repair mitral regurgitation. The malfunction prevents the device from establishing the final arm angle and clip opening while locked, which may result in unsuccessful procedures.
Contributing factors to the malfunction may include clip locking component material properties and certain use conditions. An unsuccessful clip procedure could lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
The recall applies to all lots of the affected devices, with 767 units distributed worldwide, including throughout the United States. Healthcare providers with these devices should contact Abbott Vascular for information regarding the recall.
The recalled product
- Product
- Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT…
- Manufacturer
- Abbott Vascular
- Affected units
- 767
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 (11)
- Part/UDI-GTIN: CDS0704-NT/08717648234576
- CDS0704-NTW/08717648234590
- CDS0704-XT/08717648234583
- CDS0704-XTW/08717648234606
- TCDS0203-NT/08717648229992
- TCDS0203-XT/08717648229961
- TCDS0303-NT/08717648334276
- TCDS0303-NTW/08717648334290
- TCDS0303-XT/08717648334283
- TCDS0303-XTW/08717648334306
- TCDS0203-XT/08717648229961 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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