Reported Jun 5, 2019 · Terminated
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Abbott Vascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
- Abbott MitraClip XTR Clip Delivery System
- UDI08717648226366
- PartCDS0601-XTR, Sterile EO, Rx Only
- Lot codes and dates
- All Serial Numbers.
- Amount recalled
- N/A
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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