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DLP® 12001Recalls & reported problems

Medtronic, Inc. · SUCTION 12001 LV VENT 13FR PVC 20PK 17L · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K834039); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Mar 19, 2024Open, Classified

    Potential for unsealed sterile packing.

    Z-1797-2024 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K834039. One submission often covers many models, so check the product and lot details in each record.

  • Z-2480-2025 · Aug 6, 2025 · Open, Classified
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
  • Z-2482-2025 · Aug 6, 2025 · Open, Classified
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
  • Z-2481-2025 · Aug 6, 2025 · Open, Classified
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

Other Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices

All Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.