DLP® 80220Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169485734), received between Aug 13, 2020 and Aug 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 (K840002); 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-1793-2024 · 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.

• MalfunctionAug 13, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, AS THE CUSTOMER WAS REMOVING THE CANNULA THE METAL TIP DISLODGED/SEPARATED FROM THE CANNULA BODY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10402062 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K840002. One submission often covers many models, so check the product and lot details in each record.

• Z-0986-2025 · Dec 12, 2024 · Open, Classified
  Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
• Z-1927-2008 · May 9, 2008 · Terminated
  Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022.