# FDA recall Z-1644-2025

> **Abbott** · Class II · device recall initiated 2025-03-17.

## Product

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.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1644-2025
- **Recalling firm:** Abbott
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-17
- **Report date:** 2025-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2025

## Citation

> AI Analytics. FDA recall Z-1644-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1644-2025. Source: US FDA. Licensed CC0.

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