Summary
The FDA issued a Class II for Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 by Abbott. Reason: 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 m.
Details
Source
Device Recall
External ID
Z-1644-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
Product Description
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Lot/Code Info: 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
Quantity Affected: 2683
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-17
Company
Plymouth, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott has 21 FDA actions in our database, including 15 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott have FDA actions?
Abbott has 21 FDA actions in our database, including 15 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1644-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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