DLP® 12016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994540434), received between Dec 2, 2024 and Mar 12, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

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

2 other recalls 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. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Contamination; Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETERS, IT WAS REPORTED THAT HAIR WAS DISCOVERED INSIDE THE STERILE PACKAGING OF THE DEVICE. THE HAIR WAS VISIBLE WITHIN THE SEALED STERILE PACK, BEFORE THE PACK WAS OPENED. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579693 ↗
• InjuryDec 2, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP LEFT HEART VENT CATHETER, IT WAS REPORTED THAT THE DEVICE WAS PLACED BY THE CUSTOMER DURING THE CANNULATION OF BYPASS. AT THE TIME OF THE INITIAL INSERTION, THE DEVICE WAS VISUALIZED AS INTACT/WHOLE. ONCE ONBYPASS, THE CUSTOMER OPENED THE ATRIUM AND OBSERVED THE TIP OF THE VENT SEPARATED OR TRANSECTED IN THE ATRIUM. THE LOCATION OF THE CRACK WAS A COUPLE OF INCHES FROM THE TIP. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE USE OF THE DEVICE WAS UNSPECIFIED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819747 ↗

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
• Z-2505-2021 · Aug 24, 2021 · Open, Classified
  DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only