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Open, Classified

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

FDA Recall Z-1643-2025 · Posted 2025-04-21

Recalling FirmAbbott
Recall StatusOpen, Classified
Product CodeDQY
Date Initiated2025-03-17
Product Quantity4,850

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.

Firm Action

On March 17, 2025, the firm notified customers via hand-delivered customer communications titled "Urgent Medical Device Recall." Customers were instructed to share the notice with applicable personnel and to return any remaining unused devices from impacted lots. Abbott representatives will assist with product return and replenishment. If you have any questions, please contact your local Sales Representative or Abbott Support at 1-800-544-1664.

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131063AMPLATZER TORQ VUE LP DELIVERY SYSTEMSt Jude Medical · 2013-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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