🔍 RecallPedia

CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.

Class I - Dangerous
🏥 Medical Devices Recalled: August 15, 2016 Biosense Webster Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    V 3.2: 2258, 10284, 10332, 10345, 11640, 11642, 60011, 60012, 60606, 60611, 60613, 60618, 60621, 60625, 60634, 60644, 60651, 60654, 60657, 60658, 60660, 60661, 60664, 60671, 60673, 60674, 60680, 60682, 60683, 61000, 61002, 61005, 61010, 61014, 61038, 61039, 61041, 61045, 61046, 61050, 61055, 61060, 61062, 61064, 61071, 61501, 66114, 66115, 66117, 66118, 66119, 29306, 13173, 13213, 11567, 14528 V 4.3: 61053, 61054, 61059, 11701, 12664 V 2.3: 14218, 13208, 50203, 50531, 14718, 50573
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Biosense Webster, Inc.
Reason for Recall:
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.

Product Codes/Lot Numbers:

V 3.2: 2258, 10284, 10332, 10345, 11640, 11642, 60011, 60012, 60606, 60611, 60613, 60618, 60621, 60625, 60634, 60644, 60651, 60654, 60657, 60658, 60660, 60661, 60664, 60671, 60673, 60674, 60680, 60682, 60683, 61000, 61002, 61005, 61010, 61014, 61038, 61039, 61041, 61045, 61046, 61050, 61055, 61060, 61062, 61064, 61071, 61501, 66114, 66115, 66117, 66118, 66119, 29306, 13173, 13213, 11567, 14528 V 4.3: 61053, 61054, 61059, 11701, 12664 V 2.3: 14218, 13208, 50203, 50531, 14718, 50573

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2776-2016

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