DLP® 12118Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169086702), received between Jul 9, 2017 and Jul 9, 2017 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K834352); 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. Aug 24, 2021Open, Classified

   Potential for a wire protrusion through the left heart vent catheter tip

   Z-2505-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING CANNULATION, THE CANNULA WAS PLACED THROUGH THE ATRIAL SEPTUM AND PERFORATED THE POSTERIOR WALL OF THE LEFT ATRIUM OF THE HEART. THE SURGEON SUTURED THE WALL OF THE ATRIUM. THERE WERE NO FURTHER ADVERSE PATIENT EFFECTS.

  Patient problems: Atrial Perforation

  MAUDE report 6696295 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K834352. One submission often covers many models, so check the product and lot details in each record.

• Z-2504-2021 · Aug 24, 2021 · Open, Classified
  DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only