—#185772

Product

Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 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.

FDA product code: DRC — Trocar
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Catalog Number FND-019-02 , Lot Number E1913645 ; UDI:( 01)00884450489369

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-01-19
Terminated: 2022-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185772. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.