Merit Medical Systems, Inc. Recall 87306
Description: 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 solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula.
Merit Medical Systems, Inc. Recall 87306 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1263-2021 |
| Event ID | 87306 |
| Event Description | 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 solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula. |
| Product Type | Devices |
| 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. |
| Quantity | 448 Units |
| Recall Reason | 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. |
| Device Classification | 20210324 |
| Device Code Info | Catalog Number FND-019-02 , Lot Number E1913645 ; UDI:( 01)00884450489369 |
| Center Classification Date | 20210316 |
| Recall Initiation Date | 20210119 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
| Similar To |