Merit Medical Systems, Inc.: 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.

Agency Publication Date: March 16, 2021

Affected Products

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.

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

Lot Numbers:

Number

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.

Catalog Number FND-019-02 , Lot Number E1913645 ; UDI:( 01)00884450489369

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87306

Status: Resolved

Manufacturer: Merit Medical Systems, Inc.

Manufactured In: United States

Units Affected: 2 products (587 Units; 448 Units)

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Sources: FDA iRES · Raw API Response

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Affected Products

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

Lot Numbers:

Number

Catalog Number FND-019-02 , Lot Number E1913645 ; UDI:( 01)00884450489369

Lot Numbers:

Number