Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Reported: April 30, 2025 Initiated: March 17, 2025 #Z-1643-2025
Product Description
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
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.
Details
- Recalling Firm
- Abbott
- Units Affected
- 4,850
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080. Recalled by Abbott. Units affected: 4,850.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1643-2025.
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