DLP® 94975Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169454839), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K953945); 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.

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.

• InjuryFeb 18, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF, THE CUSTOMER REPORTED A LEAK FROM THE BLUE CONNECTION POINT. THIS WAS NOTICED IMMEDIATELY UPON FIRST USE. THE CANNULA WAS USED UNDER NORMAL CONDITIONS WITH NO UNUSUAL HANDLING AND SHARP OBJECTS NEARBY. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK WAS NOTICED AT THE STAGE WHEN THE RETRO CANNULA HAD BEEN PLACED IN POSITION, MEANING THE CANNULA HAD BEEN EXPOSED TO BLOOD. THE DEFECTIVE LEAK POINT WAS AT THE BLUE CONNECTION OF THE CANNULA, NOT IN THE PARTS INSIDE THE PATIENT. THE CANNULA WAS ALREADY PLACED IN THE PATIENT AND WAS NOT REPLACED, BUT THE LEAKING AREA WAS TAPED DURING THE PROCEDURE. THE CUSTOMER STATED THAT DUE TO THE DEFECT, THE RETRO CANNULA HAD TO BE REFILLED SEVERAL TIMES. THE DEFECTIVE CANNULA PROLONGED THE DURATION OF THE SURGERY AND MADE MONITORING MORE DIFFICULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375300 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953945. One submission often covers many models, so check the product and lot details in each record.

• Z-2217-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
• Z-2222-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
• Z-2214-2026 · Apr 21, 2026 · Open, Classified
  Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
• Z-2220-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
• Z-2219-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
• Z-2221-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
• Z-2218-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
• Z-2216-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter