# FDA recall Z-1263-2021

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2021-01-19.

## 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.

## 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

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.

## Key facts

- **Recall number:** Z-1263-2021
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-19
- **Report date:** 2021-03-24
- **Termination date:** 2022-05-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1263-2021

## Citation

> AI Analytics. FDA recall Z-1263-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1263-2021. Source: US FDA. Licensed CC0.

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