FDA Device recall Z-2504-2021
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only by Medtronic Perfusion Systems, citing potential for a wire protrusion through the left heart vent catheter tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2504-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-24 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Reason
Potential for a wire protrusion through the left heart vent catheter tip
Identifiers
| code_info | Model/Reference Number 12116, Lot Number (GTIN Number): 2018080039 (20643169086719), 2018091020 (20643169086719), 2018…Model/Reference Number 12116, Lot Number (GTIN Number): 2018080039 (20643169086719), 2018091020 (20643169086719), 2018100911 (20643169086719), 2018111023 (20643169086719), 2018111419 (20643169086719), 2019120925 (20643169086719), 2018080039 (00673978462943), 2018091020 (00673978462943), 2018100911 (00673978462943), 2018111023 (00673978462943), 2018111419 (00673978462943), 2018120581 (20643169086719), 2018120581 (00673978462943), 2018120582 (20643169086719), 2018120582 (00673978462943), 2018121084 (20643169086719), 2018121084 (00673978462943), 2019010456 (20643169086719), 2019010456 (00673978462943), 2019010764 (20643169086719), 2019010764 (00673978462943), 2019020136 (20643169086719), 2019020136 (00673978462943), 2019020368 (20643169086719), 2019020368 (00673978462943), 2019020758 (20643169086719), 2019020758 (00673978462943), 2019030720 (20643169086719), 2019030720 (00673978462943), 2019031167 (20643169086719), 2019031167 (00673978462943), 2019040262 (20643169086719), 2019040262 (006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2504-2021%22
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