Z-1263-2021 Class II Terminated
FDA device recall Z-1263-2021 was initiated by Merit Medical Systems, Inc. on January 19, 2021 and is designated Class II. 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 anatom… The recall status is terminated (terminated May 17, 2022). Affected quantity: 448 Units.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- January 19, 2021
- Termination Date
- May 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 448 Units
Product Description
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.
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.
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.
Code Information
Catalog Number FND-019-02 , Lot Number E1913645 ; UDI:( 01)00884450489369