Use cautionMedical device recall · FDA · Published January 19, 2021
Merit Medical Heartspan Transseptal Needles Recall: Incorrect Tip Curvature Risk
Merit Medical recalls Heartspan Transseptal Needles (Catalog FND-019-02, Lot E1913645) due to possible incorrect needle tip curvature causing unintended anatomy punctures requiring medical intervention.
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.
Take action
Contact the company
📍Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416
“Merit Medical Heartspan Transseptal Needles Recall: Incorrect Tip Curvature Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63369-merit-medical-heartspan-transseptal-needles-recall-incorrect-tip-curvature-risk. Based on FDA recall #Z-1263-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1263-2021%22&limit=1).
Merit Medical Systems, Inc. recalled Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 due to a potential mismatch between the labeled and actual needle tip curvature, which could cause unintended anatomy puncture. The Food and Drug Administration announced the voluntary Class II recall on Jan. 19, 2021.
How to tell if you have it
Brand: Merit Medical Systems
Product: Heartspan Transseptal Needles
Catalog No.: FND-019-02
Lot No.: E1913645
UDI: (01)00884450489369
Units affected: 448
The hazard
The labeled needle tip curvature of specific lots may not match the actual needle tip curvature. If an incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
Context
GovInfoNow's records show Merit Medical Systems, Inc. has 37 other recalls on record since Feb. 24, 2006. Other recent recalls of similar products include Embosphere 500-700 Micrometer Syringe Recall (Aug. 10, 2026), Merit Medical Splashwire Hydrophilic Guide Wire Recall (May 8, 2026), Philips Bridge Prep Kit Recall (April 2, 2026), DeRoyal Myocardial Probe Recall (Aug. 20, 2026), B. Braun 21G Winged Infusion Needle Recall (Feb. 2, 2026), and Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall (Nov. 6, 2025).
How to tell if you have this one
Check for Catalog Number FND-019-02 and Lot Number E1913645 on the needle packaging. The product includes an outer needle cannula and an inner stylet.
Brand
Merit Medical Systems
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-1262-2021
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
587 Units
Z-1263-2021
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
448 Units
Based on the official FDA remedy
What to do — step by step
Check Needle Details
Verify the catalog number (FND-019-02) and lot number (E1913645) on the needle packaging.
Where it went and when
Where it was distributed
Distributed in 17 states and D.C..
Listed by the agency
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Connecticut, District of Columbia, Georgia, Kentucky, Louisiana, Maryland, Michigan, Montana, Nebraska, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia, Washington.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1263-2021 (January 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1263-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.