NA DLP11W14RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000644260), received between Oct 29, 2024 and Nov 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K924529); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• MalfunctionNov 20, 2024Material Puncture/Hole; Material Deformation; Packaging Problem; Material Puncture/Hole; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CANNULA KIT THE CUSTOMER REPORTED A CRACK/BREAK/HOLE IN THE PACKAGING. THE C RACK/BREAK/HOLE WAS 4 MM IN SIZE. THE CUSTOMER ALSO REPORTED A KINK JUST BEFORE THE Y CONNECTOR. THE KINK WAS NOT IN THE LOCATION OF THE SUTURES.THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732119 ↗
• MalfunctionOct 29, 2024Material Puncture/Hole; Material Deformation; Packaging Problem; Material Puncture/Hole; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP CANNULA KIT HAD A CRACK/BREAK/HOLE IN THE PACKAGING. THE CRACK/ BREAK/HOLE WAS 4MM IN SIZE. THE CUSTOMER ALSO REPORTED A KINK JUST BEFORE THE Y CONNECTOR. THE KINK WAS NOT IN THE LOCATION OF THE SUTURES. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20555090 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924529. One submission often covers many models, so check the product and lot details in each record.

• Z-0826-2017 · Nov 16, 2016 · Terminated
  Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Art
• Z-1023-2016 · Feb 4, 2016 · Terminated
  Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvet