[pending] Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Pending LLM rewrite. Source: FDA_DEVICE Z-1644-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
- Manufacturer
- Abbott
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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