The Recall Desk
HighFDA (Devices)·Z-0116-2023·Announced 2022-10-26

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.

What this means for you

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, Mi
Manufacturer
Abbott Vascular
Category
Medical Device — Cardiac / Valve Repair
Hazard
  • clip-locking-malfunction
  • device-embolization
  • tissue-injury

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

Distributed nationwide across the United States.

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