DLP® 71424Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20643169084524), received between Jul 21, 2022 and Jun 30, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K840001); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS ARTERIAL FLEX CANNULA THE USER REPORTED THAT THE RING WAS TOO LOOSE. THE CANNULA WAS REPLACED AND THERE WAS NO PATIENT INVOLVED WITH THIS EVENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237068 ↗
• MalfunctionJul 27, 2022Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP FLEXIBLE ARCH ARTERIAL CANNULA, IT WAS REPORTED THAT THE CUFF ON THE CANNULA WAS LOOSE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15110951 ↗
• InjuryJul 21, 2022Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP FLEXIBLE ARCH ARTERIAL CANNULA, IT WAS REPORTED THAT THE CUFF ON THE CANNULA WAS LOOSE.  THE CUFF FROM THE CANNULA FELL INTO THE PATIENT'S CHEST CAVITY, THE CUFF WAS RETRIEVED AND THERE WERE NO FURTHER COMPLICATIONS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUFF WAS RETRIEVED WHEN THE PATIENT¿S CHEST WAS STILL OPEN. IT WAS VISIBLE IN THE CHEST CAVITY AND THE SURGEON WAS ABLE TO EASILY RETRIEVE IT AND THE PATIENT WAS NOT AFFECTED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FORCEPS WERE USED TO REMOVE THE CUFF. THE CUSTOMER STATED THAT IT WAS REMOVED UNDER DIRECT VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073257 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K840001. One submission often covers many models, so check the product and lot details in each record.

• Z-1925-2008 · May 9, 2008 · Terminated
  Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog Numbers: CB71424, CB77008, and CB77010.