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Biosense Webster Inc

United States US-MF-000014219 Last updated 23 Oct 2026

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Devices
673
Registries
EUDAMEDGUDIDFDA
FDA recalls
624 ongoing

Catalogue673

Page 1 of 14

Showing 1-50 of 673

EUDAMED certificates3

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (3)

Notified body 0344 2 certificates

  • 3903009CE01 Reissued

    Quality management system EU MDR

    Issued
    1 Sep 2026
    Expires
    1 Sep 2031
  • 3903009CE07 Reissued

    Quality management system EU MDR

    Issued
    1 Jun 2026
    Expires
    1 Jun 2031

Notified body 2797 1 certificate

  • MDR 825396 Supplemented

    Technical documentation EU MDR

    Issued
    22 Jun 2026
    Expires
    26 Jan 2031
    Reason
    Change approved

Related companies

Notified bodies

  • Notified body 0344
  • Notified body 2797

FDA recalls62

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 62 recalls.

  • 2025

    • 5 Jan 2025 Z-1205-2025 Class I Completed Due to an observed trend of neurovascular events

  • 2024

    • 16 Feb 2024 Z-1290-2024 Class II Ongoing Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

  • 2023

    • 21 Feb 2023 Z-1319-2023 Class II Ongoing Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
    • 21 Feb 2023 Z-1320-2023 Class II Ongoing Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

  • 2022

    • 29 Jun 2022 Z-1677-2022 Class II Ongoing Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.

  • 2021

    • 26 Feb 2021 Z-1285-2021 Class II Completed There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
    • 26 Feb 2021 Z-1286-2021 Class II Completed There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
    • 26 Feb 2021 Z-1287-2021 Class II Completed There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

  • 2020

    • 22 Apr 2020 Z-2371-2020 Class II Terminated Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
    • 22 Apr 2020 Z-2372-2020 Class II Terminated Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Show the 25 most recent of 62 recalls

  • 2018

    • 7 May 2018 Z-2878-2018 Class I Terminated When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or failure to recapture the device.

  • 2017

    • 6 Sep 2017 Z-0054-2018 Class II Terminated Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
    • 6 Sep 2017 Z-0055-2018 Class II Terminated Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
    • 6 Sep 2017 Z-0056-2018 Class II Terminated Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
    • 6 Sep 2017 Z-0057-2018 Class II Terminated Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
    • 6 Sep 2017 Z-0058-2018 Class II Terminated Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
    • 14 Jun 2017 Z-0210-2018 Class II Terminated Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
    • 17 May 2017 Z-0211-2018 Class II Terminated Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
    • 17 May 2017 Z-0212-2018 Class II Terminated Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.

  • 2016

    • 15 Aug 2016 Z-2776-2016 Class II Terminated Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).
    • 14 Apr 2016 Z-1590-2016 Class II Terminated Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.
    • 14 Apr 2016 Z-1591-2016 Class II Terminated Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.

  • 2015

    • 10 Sep 2015 Z-0002-2016 Class II Terminated Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.
    • 10 Sep 2015 Z-0003-2016 Class II Terminated Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.
    • 17 Apr 2015 Z-1525-2015 Class II Terminated The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.

FDA establishments1

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

  • Biosense Webster, Inc. JUAREZ Chihuahua · MX FEI 3003248396

Information

Country
United States
Address
31, Technology Drive, Suite 200, Irvine, California, United States
Website
its.jnj.com
Phone
+1(800)729-9010
PRRC contact
Tucky Wong
EUDAMED SRN
US-MF-000014219
FDA FEI number
3022451073
DUNS number
020163218