Heartspan Transseptal Needles — Class II medical device recall Z-1263-2021
Terminated recall by Merit Medical Systems, Inc., reported 2021-03-24, distributed in AL, CA, CT, DC, GA, KY, LA, MD…. The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip c
| Recall number | Z-1263-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2021-01-19 |
| Classified | 2021-03-16 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2022-05-17 |
| Distributed | AL, CA, CT, DC, GA, KY, LA, MD, MI, MT, NE, NJ, NY, PA, TX, UT, VA, WA |
| Quantity | 448 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884450489369 |
| Lot numbers | E1913645 |
| Model numbers | FND-019-02 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1263-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.