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Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

FDA Recall #Z-1644-2025 — Class II — March 17, 2025

Recall #Z-1644-2025 Date: March 17, 2025 Classification: Class II Status: Ongoing

Product Description

Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

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.

Recalling Firm

Abbott — Plymouth, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2683

Distribution

Worldwide - US Nationwide distribution.

Code Information

UDI-DI 00811806012926 Lots 9078966 9093895 9134623 9144113 9148110 9148579 9155868 9158302 9241591 9241593 10004059 10011461 10011462 10011463 10011465 10017790 10017792 10196106 10196119 10198795 10198801 10198889 10207472 10207503 10274454 10283818

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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