DLP® 94735Recalls & reported problems
Medtronic, Inc. · CANNULA 94735 RCSP SIL AUTO 15FR 10PK · Class 2
All models of DLP (151)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20643169454754), received between Jul 23, 2025 and Mar 4, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A GUNDRY SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THERE WAS WATER LEAKAGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510743 ↗InjuryJul 23, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT DURING USE OF THE DLP SILICONE RCSP CANNULA WITH AN AUTO-INFLATE CUFF, THE WHITE CLIP ON THE CANNULA LINE PIERCED THE SILICONE AND CREATED A HOLE. THE SURGEON WAS REQUIRED TO PLUG THE HOLE WITH A FINGER DURING CARDIOPLEGIA ADMINISTRATION. THERE WAS NO METAL CLAMP USED ON THE LINE AND THE PIERCING RESULTED PURELY FROM THE APPLICATION OF THE CLIP. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WHETHER THERE WERE ANY ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT IS UNKNOWN. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO PATIENT IMPACT. LEAK WAS FROM THE BODY OF THE CANNULA. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE DAMAGE WAS WHERE THE WHITE CLIP ON THE CANNULA LINE WAS PLACED. MINIMAL BLOOD LOSS, THE SURGEON WAS ABLE TO PLUG THE HOLE WITH THEIR FINGER, AND NO TRANSFUSION WAS NEEDED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574598 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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