Abbott recalls Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

Recall date

March 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1643-2025

FDA classification

Class II

Brand / firm

Abbott

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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