Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Q823423, Exp 7/31/2018
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Merit Medical Systems, Inc.
- Reason for Recall:
- Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50¿ curve, rather than the correct 86¿ curve
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
Product Codes/Lot Numbers:
Lot Q823423, Exp 7/31/2018
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1375-2016
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