nGEN Generator D138402

• FDA PMA P040036 decided 11 Aug 2006 Active· +5 more in the status table
• EUDAMED Active
• FDA GUDID UDI-DI 10846835018080 listed 18 Aug 2022 Listed

• • 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-0058-2018 FDA Class II ·initiated 6 Sep 2017

  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.

• • Terminated Z-0139-2015 FDA Class II ·initiated 19 Oct 2014

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

• • Terminated Z-3178-2011 FDA Unclassified (pre-2012) ·initiated 7 Jul 2011

  Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator, to communicate undetected software anomalies in the form of software release note in order to amend the labeling and thereby enhance the safety of the product.

• 5 recalls, same reason

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

  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-0369-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2008

  Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. Therefore the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to u

• • Terminated Z-0057-06 FDA Unclassified (pre-2012) ·initiated 8 Aug 2005

  Increased complaints regarding catheters with leaks and flow obstruction.

• • Terminated Z-1328-04 FDA Unclassified (pre-2012) ·initiated 16 Jul 2004

  Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.

1. 22 Nov 2010 Recall initiated FDA recalls Z-0982-2012
2. 22 Nov 2010 Recall initiated FDA recalls Z-0981-2012
3. 22 Nov 2010 Recall initiated FDA recalls Z-0979-2012
4. 22 Nov 2010 Recall initiated FDA recalls Z-0983-2012
5. 22 Nov 2010 Recall initiated FDA recalls Z-0980-2012
6. 7 Jul 2011 Recall initiated FDA recalls Z-3178-2011
7. 19 Oct 2014 Recall initiated FDA recalls Z-0139-2015
8. 6 Sep 2017 Recall initiated FDA recalls Z-0058-2018
9. 18 Aug 2022 Listed FDA GUDID 10846835018080
10. 7 Sep 2022 Recall initiated FDA recalls Z-0169-2023

9 earlier events are in the sections above.

Trade name

nGEN Generator

Generic name

Cardiac radio-frequency ablation system generator

Model / Ref / Catalog

D138402

Primary DI / UDI-DI

10846835018080

PMA number

P010068 ↗

P030031 ↗

P040036 ↗

P950005 ↗

P990025 ↗

P990071 ↗

FDA product code

LPB, OAE, DRF, OAD

GMDN term

Cardiac radio-frequency ablation system generator

Device class

Class III

Regulation number

870.1220

GUDID distribution status

In Commercial Distribution

Category: Cardiac radio-frequency ablation system generator

Other devices filed under FDA product code LPB (Cardiac ablation percutaneous catheter).

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• Blazer II Cardiac Ablation Catheter and Cable by Boston Scientific
• iCONNECT - AMPERE 82066 001-009079-1 by Osypka AG
• Helios II Ablation Catheter by Stereotaxis, Inc.
• 7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System by Medtronic Cryocath, LP
• Ampere™ H701337 by ST. JUDE MEDICAL, INC.
• RF CONTACTR CATHETER, RF ENHANCR II CATHETER, RF MARINR CATHETER, RF CONDUCTR CATHETER by MEDTRONIC, INC.

• Webster Electrophysiology Catheter

  Class III

  CE/MDD

• TRUPULSE Generator

  Class IIb

  CE/MDR 3903009CE01 Active Valid to Sep 2031

• Carto Vizigo D138505 Open recall

  Class II

  FDA 510(k) K170997 Active Cleared 25 Jul 2017 GUDID on market

• Dual Energy Thermocool Smarttouch SF Catheter D134713 Open recall

  Class III

  FDA PMA P030031 Active Approved 5 Nov 2004 GUDID on market

See all devices from Biosense Webster Inc →