DLP Left Heart Vent Catheters — Class II medical device recall Z-2504-2021
Ongoing recall by Medtronic Perfusion Systems, reported 2021-09-29, distributed nationwide. Potential for a wire protrusion through the left heart vent catheter tip
| Recall number | Z-2504-2021 |
|---|---|
| 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 | 2021-08-24 |
| Classified | 2021-09-22 |
| Reported by FDA | 2021-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BR, CA, CH, CL, CO, CR, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JM, JO, JP, KE, LB, LU, LV, MA, MX, MY, NG, NO, NP, NZ, PH, PK, PL, RO, RS, SA, SE, SG, SI, TH, TN, TR, TW, UA, VN |
| Quantity | 51,494 units |
| UPC / GTIN / UDI-DI | 00673978462943, 20643169086719 |
| Lot numbers | 2018080039, 2018080040, 2018090064, 2018090434, 2018091019, 2018091020, 2018100118, 2018100522, 2018100911, 2018101295, 2018101296, 2018111023, 2018111418, 2018111419, 2018111420, 2018120581, 2018120582, 2018121083, 2018121084, 2019010456, 2019010764, 201901C047, 201901C048, 201901C049, 2019020136, 2019020368, 2019020758, 2019020759, 201902C156, 2019030720, 2019031167, 2019040262, 2019040472, 2019040473, 2019041189, 2019050576, 2019051126, 201905C012, 2019060218, 2019060423 and 92 more |
Product
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Reason for recall
Potential for a wire protrusion through the left heart vent catheter tip
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-2504-2021. 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.