Abbott MitraClip and TriClip Clip Delivery Systems: Locking Malfunction Risk
Abbott is recalling MitraClip and TriClip Clip Delivery Systems due to clip locking malfunctions. Failed procedures may result in mitral regurgitation recurrence, 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 medical device recall presents risk of serious patient harm through potential device malfunction during cardiac procedures, including device embolization and tissue injury. No hospitalizations or injuries have been reported, placing this in the High severity category per the rubric for risk-of-harm products without yet-reported injury.
Plain-English summary
Abbott Vascular has recalled MitraClip and TriClip Clip Delivery System models used in cardiac procedures to repair mitral valve regurgitation. The recall affects 20,045 units distributed worldwide, including throughout the United States and multiple international markets.
The recall addresses an increase in clip locking malfunctions affecting the clip's final arm angle and opening positioning. These malfunctions may result from clip locking component material properties and certain use conditions encountered during cardiac procedures.
When clip delivery system procedures are unsuccessful due to these malfunctions, patients may experience serious complications including recurrence of severe mitral regurgitation, device embolization (unintended device displacement), or tissue injury.
Hospitals and physicians should review the recall details with Abbott Vascular and follow company guidance regarding affected systems. Patients who have undergone or are scheduled for procedures using these devices should discuss the recall with their healthcare provider.
The recalled product
- Product
- Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW…
- Manufacturer
- Abbott Vascular
- Affected units
- 20,045
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 (20)
- Part/UDI-GTIN: CDS0601-NTR/08717648226342
- CDS0602-NTR/08717648226359
- CDS0602-XTR/08717648226373
- CDS0702-NT/08717648230950
- CDS0702-NTW/08717648230974
- CDS0702-XT/08717648230998
- CDS0702-XTW/08717648231018
- CDS0705-NT/08717648288616
- CDS0705-NTW/08717648288630
- CDS0705-XT/08717648288623
- CDS0705-XTW/08717648288647
- TCDS0202-XT/08717648229978
- TCDS0202-NT/08717648229985
- TCDS0205-XT/08717648288708
- TCDS0205-NT/08717648288692
- TCDS0302-NT/08717648334238
- TCDS0302-NTW/08717648334252
- TCDS0302-XT/08717648334245
- TCDS0302-XTW/08717648334269
- TCDS0305-NT/08717648334313
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
Same manufacturer · Abbott Vascular
See all →- HighMitraClip G4 and TriClip G4 Cardiac Devices Recalled for Clip Locking Malfunction
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