Merit Medical Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1262-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 19, 2021

Date Posted: March 24, 2021

Recall Number: Z-1262-2021

Event ID: 87306

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.

Status: Terminated

Product Quantity: 587 Units

Code Information:

Catalog Number FND-019-01, Lot Number E1913644; UDI: (01)00884450489345

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.

Voluntary or Mandated:

Voluntary: Firm initiated