Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 24, 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.
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,…
Merit Medical Systems, Inc. recalled HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an … - a moderate-severity action.
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an … was recalled by Merit Medical Systems, Inc. in March 24, 2021. Reason: The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip …. Check the official notice for the remedy. Verify recall #Z-1262-2021 with the FDA Devices before acting.
The recall
Merit Medical Systems, Inc. issued this moderate-severity FDA Devices recall-The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip ….
- Moderate
- severity level
- 587 units
- affected scope
- Class II
- classification
- March 24, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1262-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1262-2021) was formally reported on March 24, 2021, with the manufacturer initiating the action on January 19, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Merit Medical Systems, Inc. is listed as the recalling firm, operating out of South Jordan, UT. Federal records list the affected scope as 587 Units.
The documented reason for this recall is: 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 occu… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
587 Units
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1262-2021 |
| Date reported | March 24, 2021 |
| Date initiated | January 19, 2021 |
| Recalling firm | Merit Medical Systems, Inc. |
| Firm location | South Jordan, UT |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1262-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merit Medical Systems, Inc.. Units affected: 587 Units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 24, 2021. Severity: Moderate. Recall number: Z-1262-2021.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1262-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 24, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.