Class 2 Device Recall HeartSpan Transseptal Needles

• Date Initiated by Firm: January 19, 2021
• Create Date: March 16, 2021
• Recall Status: Terminated on May 17, 2022
• Recall Number: Z-1262-2021
• Recall Event ID: 87306
• Product Classification: Trocar - Product Code DRC
• Product: HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula.
• Code Information: Catalog Number FND-019-01, Lot Number E1913644; UDI: (01)00884450489345
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-208-4381
• Manufacturer Reason for Recall: The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
• FDA Determined Cause: Process control
• Action: Urgent Product Recall Notices were sent to consignees via FedEx overnight delivery beginning on January 19, 2021. The notification included product identification information, instructions to determine if any of the devices listed in the Customer Response Form (CRF) were within the consignees' faciltiies, quarantine them, and to discontinue distribution, and return product to Merit. Consignees were also requested to ensure that applicable personnel within their organizations were made aware of this field action; if the product has been further distributed to other facilities, institutions, or manufacturers, to ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Consignees were requested to fill out, scan and email the completed Customer Response Form to Customer Service at response@merit.com within 10 business days, and to ensure all affected product shipped to the consignee has been accounted for on the CRF. Finally, customers were requested to immediately return all affected lots in their possession to Merit, per the instructions in the attached CRF. Consignees were informed that adverse events experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch or by phone at 1-800-332-1088. Customers with questions may contact their Merit Sales Representative or Merit Customer Service at (801) 208-4381 | Hours: 6 am to 6 pm MST | Mon-Fri. Merit Sales Representatives with affected accounts were provided a courtesy notification via email which included a copy of the Recall Notice and CRF which was mailed to their accounts. The courtesy email also included instructions to assist their accounts with product return as requested by the account.
• Quantity in Commerce: 587 Units
• Distribution: U.S. Consignees: VA, NE, Washington DC, MI, NY, KY, CA, TX, MD, AL, GA, UT, LA, CA, CT, PA, WA, MT and NJ. No government consignees. Also distributed OUS.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.