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Abbott Vascular

United States US-MF-000003850 Last updated 23 Oct 2026

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Devices
1,986
Registries
EUDAMEDFDA
FDA recalls
4913 ongoing

Catalogue1,986

Page 1 of 40

Showing 1-50 of 1,986

FDA recalls49

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 49 recalls.

  • 2024

    • 6 Nov 2024 Z-0730-2025 Class II Ongoing Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.via FDA establishment ABBOTT VASCULAR
    • 6 Nov 2024 Z-0731-2025 Class II Ongoing Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.via FDA establishment ABBOTT VASCULAR
    • 6 Nov 2024 Z-0732-2025 Class II Ongoing Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.via FDA establishment ABBOTT VASCULAR
    • 6 Nov 2024 Z-0733-2025 Class II Ongoing Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.via FDA establishment ABBOTT VASCULAR

  • 2022

    • 8 Sep 2022 Z-0115-2023 Class II Ongoing An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.via FDA establishment ABBOTT VASCULAR
    • 8 Sep 2022 Z-0116-2023 Class II Ongoing An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.via FDA establishment ABBOTT VASCULAR
    • 8 Sep 2022 Z-0117-2023 Class II Ongoing An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.via FDA establishment ABBOTT VASCULAR
    • 30 Mar 2022 Z-1095-2022 Class I Ongoing There is a potential that the proximal marker may separate from the imaging cathetervia FDA establishment ABBOTT VASCULAR
    • 11 Mar 2022 Z-0921-2022 Class II Ongoing Due to an increase in complaint trend for leaks and intermittent/loose connections.via FDA establishment ABBOTT VASCULAR
    • 11 Mar 2022 Z-0922-2022 Class II Ongoing Due to an increase in complaint trend for leaks and intermittent/loose connections.via FDA establishment ABBOTT VASCULAR
Show the 25 most recent of 49 recalls

  • 2022

    • 11 Mar 2022 Z-0923-2022 Class II Ongoing Due to an increase in complaint trend for leaks and intermittent/loose connections.via FDA establishment ABBOTT VASCULAR
    • 11 Mar 2022 Z-0924-2022 Class II Ongoing Due to an increase in complaint trend for leaks and intermittent/loose connections.via FDA establishment ABBOTT VASCULAR
    • 11 Mar 2022 Z-0925-2022 Class II Ongoing Due to an increase in complaint trend for leaks and intermittent/loose connections.via FDA establishment ABBOTT VASCULAR

  • 2020

    • 25 Mar 2020 Z-2370-2020 Class II Terminated Incorrect expiration datevia FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1128-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1129-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1130-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1131-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1132-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1133-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1134-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1135-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1136-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1137-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR
    • 29 Jan 2020 Z-1138-2020 Class I Terminated Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.via FDA establishment ABBOTT VASCULAR

FDA establishments5

Registered with the FDA under this company group, matched by name.

  • Abbott Vascular CLONMEL Tipperary · IE FEI 3005718570
  • Abbott Vascular SANTA CLARA, CA · US FEI 3004635528
  • Abbott Vascular Barceloneta, PR · US FEI 3005737652
  • Abbott Vascular El Coyol Alajuela · CR FEI 3009564766
  • Abbott Vascular Menlo Park, CA · US FEI 3005070406

What Abbott Vascular makes

Abbott Vascular manufactures coronary and peripheral angioplasty balloon catheters, including basic and drug-eluting stents for coronary arteries, as well as bare-metal stents for coronary and carotid arteries. Their portfolio also includes guidewires for cardiac and peripheral vascular procedures, both single-use and manual types, designed for precision navigation and intervention.

The company’s devices are regulated under FDA’s Class II and Class III classifications, with some listed as unclassified, and are recorded in the FDA’s Unique Device Identifier (UDI) database. Abbott Vascular operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Abbott Vascular primarily manufacture?

Abbott Vascular specializes in vascular intervention devices, including coronary and peripheral angioplasty balloon catheters, stents for coronary and carotid arteries (both bare-metal and drug-eluting), and guidewires for cardiac and peripheral vascular procedures. These devices are designed to treat blockages or narrowings in blood vessels, improving blood flow and supporting interventional cardiology and vascular surgery.

Where is Abbott Vascular based, and how does that affect its regulatory oversight?

Abbott Vascular is headquartered in the United States, which means its devices fall under FDA regulation. The FDA classifies these devices as Class II or Class III, depending on their risk level and intended use, with some listed as unclassified. This classification determines the regulatory pathway and scrutiny required for market authorization.

Which regulatory registries or databases list Abbott Vascular’s devices?

Abbott Vascular’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and patients to identify and verify specific devices through a standardized identifier.

How are Abbott Vascular’s devices classified by the FDA, and why does this matter?

Abbott Vascular’s devices are classified under FDA’s Class II (moderate risk), Class III (high risk requiring premarket approval), or unclassified categories. This classification determines the regulatory requirements for market authorization, such as pre-market notifications (510(k)), premarket approval applications (PMA), or other compliance pathways. Higher-risk devices (Class III) undergo stricter scrutiny to ensure safety and effectiveness before approval.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
3200, Lakeside Drive, Santa Clara, United States
Phone
+1(800)227-9902
PRRC contact
Kim Swertfager
EUDAMED SRN
US-MF-000003850
FDA FEI number
2024168
DUNS number
849716605