Skip to content

Dual Energy Thermocool Smarttouch SF Catheter D134711

by Biosense Webster Inc United States GUDID

Product code QZI

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10846835026726 UDI-DIDate9 Jul 2026ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

8 recalls · 1 ongoing · FDA

    • Ongoing Z-0169-2023 FDA Class II initiated 7 Sep 2022

    Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

    • Terminated Z-0139-2015 FDA Class II initiated 19 Oct 2014 via P030031, on the same PMA

    The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.

  • 5 recalls, same reason

    • Terminated Z-0981-2012 FDA Unclassified (pre-2012) initiated 22 Nov 2010
    • Terminated Z-0983-2012 FDA Unclassified (pre-2012) initiated 22 Nov 2010
    • Terminated Z-0980-2012 FDA Unclassified (pre-2012) initiated 22 Nov 2010
    • Terminated Z-0982-2012 FDA Unclassified (pre-2012) initiated 22 Nov 2010
    • Terminated Z-0979-2012 FDA Unclassified (pre-2012) initiated 22 Nov 2010

    Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist

    • Terminated Z-0057-06 FDA Unclassified (pre-2012) initiated 8 Aug 2005 via P030031, on the same PMA

    Increased complaints regarding catheters with leaks and flow obstruction.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Dual Energy Thermocool Smarttouch SF Catheter
Generic Name
Cardiac irreversible electroporation system catheter
Model / Ref / Catalog
D134711
Primary DI / UDI-DI
10846835026726
PMA Number
FDA Product Code
QZI, OAE, OAD
GMDN Term
Cardiac irreversible electroporation system catheter
Device Class
Class III
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (P030031)

Show all (12)

Other devices from Biosense Webster Inc

See all devices from Biosense Webster Inc →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (9)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI ddf71978-bbc7-4276-86b0-5411d5cd8e71 37 fields · synced 23 Oct 2026