Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr — Class II medical device recall Z-1797-2024
Ongoing recall by Medtronic Perfusion Systems, reported 2024-05-22. Potential for unsealed sterile packing.
| Recall number | Z-1797-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2024-03-19 |
| Classified | 2024-05-10 |
| Reported by FDA | 2024-05-22 |
| Quantity | 13,954 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00613994540355, 00643169878686, 00643169880665, 00673978176307, 00673978176321, 20613994540359, 20613994540434, 20613994540465, 20613994619215, 20613994619246, 20643169878680, 20643169880669, 20643169881338 |
| Lot numbers | 2023040810, 2023040811, 2023040819, 2023040820, 2023041178, 2023041180, 2023041181, 2023041182, 2023041183, 2023041184, 2023041188, 2023041189, 2023041202, 2023050075, 2023050080, 2023050083, 2023050095, 202305C079, 202305C086, 202305C087, 202305C093, 202305C096, 202306C141, 202306C144, 202306C159, 202307C103, 2023090675 |
| Model numbers | 12001, 12002, 12008, 12010, 12012, 12016, 12113, 12220 |
Product
Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP¿ Pericardial Sump 38.1 cm (15 in), Model Number 12010,
Reason for recall
Potential for unsealed sterile packing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1797-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.