The Recall Desk
SevereFDA (Devices)·Z-1262-2021·Announced 2021-03-24

Merit Medical Recalls HeartSpan Transseptal Needles Due to Tip Curvature Mismatch

Merit Medical Systems is recalling 587 HeartSpan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the hazard is 'likely to require medical intervention,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk medical device defects requiring hospitalization/intervention.

Plain-English summary

Merit Medical Systems, Inc. is recalling 587 units of HeartSpan Transseptal Needles, Catalog No. FND-019-01, Lot No. E1913644. The recall was initiated because the labeled needle tip curvature of these specific lots may not match the actual needle tip curvature.

The FDA has classified this as a Class II recall. The source text states that if an incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention. No specific injuries or illnesses are reported in the source text.

The affected products were distributed to consignees in the United States, including Virginia, Nebraska, Washington DC, Michigan, New York, Kentucky, California, Texas, Maryland, Alabama, Georgia, Utah, Louisiana, Connecticut, Pennsylvania, Washington, Montana, and New Jersey. The products were also distributed outside the United States. No government consignees were involved. Users should stop using the affected needles and contact Merit Medical Systems for further instructions.

The recalled product

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 soli
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Needles
Hazard
Affected units
587

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Catalog Number FND-019-01
  • Lot Number E1913644
  • UDI: (01)00884450489345

Distribution

Distributed in 18 states:

Part of a larger recall action

This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · puncture injury

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