Z-1644-2025Class II

Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

Name: Z-1644-2025 Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Creator: Abbott
Published: 2025-03-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-03-17 / Open, Classified / root cause: manufacturing process

FDA source

Abbott began a recall of Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 on 2025-03-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1644-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-17
Posted: 2025-04-21
Recalling firm: Abbott Medical
Product: Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 2683
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1644-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1643-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21
Z-1644-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21

Product code DQY

K162228Class IITorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor / cleared 2016-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)