DLP® 94835Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20613994575504), received between Aug 2, 2023 and Dec 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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.

• MalfunctionDec 19, 2025Crack; Crack

  IT WAS REPORTED THAT DURING REMOVAL OF THE DLP PVC RCSP CANNULA WITH AUTO-INFLATE CUFF, THE RETROGRADE METAL INTRODUCER SNAPPED OFF.THE USE OF THE DEVICE WAS UNKNOWN.THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847485 ↗
• MalfunctionJun 10, 2025Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  IT WAS REPORTED THAT DURING USE OF AN DLP PVC RCSP CANNULA WITH AUTO-INFLATE CUFF, IT WAS IMPOSSIBLE TO INFLATE THE BALLOON. THE DEVICE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT WHEN THE AORTA WAS CLAMPED, THE RETROGRADE CARDIOPLEGIA FAILED AND THE CUSTOMER NOTICED THAT THE INSERTED CANNULA HAD COLLAPSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174696 ↗
• MalfunctionAug 2, 2023Mechanical Problem; Obstruction of Flow; Material Deformation; Mechanical Problem; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PVC RCSP CANNULA WITH AUTO-INFLATE CUFF, IT WAS REPORTED DURING EXTRACORPOREAL CIRCULATION THE CUSTOMER HAD DIFFICULTY IN PERFORMING A RETROGRADE CARDIOPLEGIA, SWITCHING TO ANTEROGRADE. AT THE END OF THE OPERATION, THE CANNULA WAS CHECKED BY THE SURGEON AND IT WAS FOUND TO BE MALFUNCTIONING. THE BLOOD FLOW WAS EXITING AT THE BASE OF THE BALLOON INSTEAD OF AT THE TIP OF THE CANNULA. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440860 ↗