The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1263-2021·Announced 2021-03-24

Heartspan Transseptal Needle Recall Due to Tip Curvature Mismatch

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The source text explicitly states that unintended anatomy puncture is 'likely to require medical intervention,' which aligns with the rubric criterion for significant injury or medical intervention reports.

Plain-English summary

Merit Medical Systems, Inc. is recalling Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645. The recall involves 448 units of the device, which consists of an outer needle cannula and an inner stylet. The product was distributed to consignees in various U.S. states, including Virginia, Nebraska, Washington DC, Michigan, New York, Kentucky, California, Texas, Maryland, Alabama, Georgia, Utah, Louisiana, Connecticut, Pennsylvania, Washington, Montana, and New Jersey, as well as outside the United States.

The recall is being issued because 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. The source text states that such an event is likely to require medical intervention.

Healthcare providers and facilities should stop using the affected lots immediately. Consumers and medical staff should check their inventory for Catalog Number FND-019-02 and Lot Number E1913645. If the product is found, it should be quarantined and returned to Merit Medical Systems, Inc. according to the firm's instructions.

The recalled product

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…
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Needles
Hazard
Affected units
448

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-019-02
  • Lot Number E1913645
  • UDI:( 01)00884450489369

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 →

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