Class II

Medical Device Recall: Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

Abbott · March 17, 2025

Reason for Recall

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

4,850

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1643-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.