The Recall Desk

FDA (Devices) recall action 87306

Merit Medical Systems, Inc. recalled 2 products on 2021-03-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-03-24
Critical
0
Units
1,035

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··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.

    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
    Category
    Distribution
    18 states
  • SevereFDA (Devices)··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.

    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 soli
    Category
    Distribution
    18 states