Z-1262-2021Class II

HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula...

Name: Z-1262-2021 HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula...
Creator: Merit Medical Systems, Inc.
Published: 2021-01-19
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2021-01-19 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of 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... on 2021-01-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1262-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-19
Posted: 2021-03-16
Terminated: 2022-05-17
Recalling firm: Merit Medical Systems, Inc.
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.
Product code: DRC Trocar
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Product Recall Notices were sent to consignees via FedEx overnight delivery beginning on January 19, 2021. The notification included product identification information, instructions to determine if any of the devices listed in the Customer Response Form (CRF) were within the consignees' faciltiies, quarantine them, and to discontinue distribution, and return product to Merit. Consignees were also requested to ensure that applicable personnel within their organizations were made aware of this field action; if the product has been further distributed to other facilities, institutions, or manufacturers, to ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Consignees were requested to fill out, scan and email the completed Customer Response Form to Customer Service at [email protected] within 10 business days, and to ensure all affected product shipped to the consignee has been accounted for on the CRF. Finally, customers were requested to immediately return all affected lots in their possession to Merit, per the instructions in the attached CRF. Consignees were informed that adverse events experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch or by phone at 1-800-332-1088. Customers with questions may contact their Merit Sales Representative or Merit Customer Service at (801) 208-4381 | Hours: 6 am to 6 pm MST | Mon-Fri. Merit Sales Representatives with affected accounts were provided a courtesy notification via email which included a copy of the Recall Notice and CRF which was mailed to their accounts. The courtesy email also included instructions to assist their accounts with product return as requested by the account.
Quantity in commerce: 587 Units
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.
Product codes and lots: Catalog Number FND-019-01, Lot Number E1913644; UDI: (01)00884450489345

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1262-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1262-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-16
Z-1263-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-16

Product code DRC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)