Z-1643-2025Class II

Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

Name: Z-1643-2025 Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
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 Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 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-1643-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-17
Posted: 2025-04-21
Recalling firm: Abbott Medical
Product: Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
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: 4,850
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Models: 1. 9-TVLP4F90/060; UDI-DI 00811806011561 Lots 9114256 9125090 9157327 9211450 10005333 10080103 10092488 10092519 10212158 10248201 10265245 10333989 10334851 10353324 2. 9-TVLP4F90/080; UDI-DI 00811806011578 Lots 9206150 10040010 10068340 10227816 10341801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1643-2025
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

K131063Class IIAmplatzer Torq Vue Lp Delivery SystemSt Jude Medical / cleared 2013-08-15

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)