Recall Z-1687-2019— Abbott Vascular
Class II · Terminated
Class II FDA medical device recall by Abbott Vascular, initiated 2019-05-01, terminated 2020-12-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only. Reason: Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention..
- Recalling firm
- Abbott Vascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-01
- Terminated
- 2020-12-11
- Firm location
- Temecula, CA, United States
Product description
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Reason for recall
Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.
Data sourced from openFDA. This site is unofficial and independent of the FDA.