Gundry® 94715Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20643169454716), received between Nov 29, 2021 and Jul 14, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (K860149); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING USE OF A GUNDRY SILICONE RCSP CANNULA WITH A MANUAL-INFLATE CUFF, THE BALLOON WAS INFLATING ON JUST ONE SIDE. THE USE OF THE DEVICE WAS UNSPECIFIED.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 22493344 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A GUNDRY SILICONE RCSP CANNULA WITH A MANUAL-INFLATE CUFF, THE BALLOON DID NOT INFLATE PROPERLY WHEN THE SURGEON ATTEMPTED TO USE THE CANNULA. THE DEVICE WAS REPLACED BY ANOTHER MEDTRONIC DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A LEAK WAS NOT OBSERVED ANYWHERE ON THE DEVICE. THERE WAS NO DAMAGE TO THE DEVICE OR BALLOON. THE CUSTOMER STATED THAT THE ISSUE WAS THAT THE BALLOON DID NOT INFLATE ALL THE WAY. ONE END OF THE BALLOON WAS INFLATED ¾ AND THE OTHER END WAS INFLATED ¼. THE DOCTOR CHECKED 3 CANNULAE BEFORE INSERTING INTO TO THE PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER OBSERVED THE ISSUE WHEN PERFORMING THE WATER TEST. THE BALLOON WAS INFLATING ¾ FROM 1 CORNER AND ¼ FROM THE OTHER CORNER WHICH NORMALLY THE INFLATING SHOULD BE CENTRALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401222 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A GUNDRY SILICONE RCSP CANNULA WITH A MANUAL-INFLATE CUFF, THE BALLOON DID NOT INFLATE PROPERLY WHEN THE SURGEON ATTEMPTED TO USE THE CANNULA. THE DEVICE WAS REPLACED BY ANOTHER MEDTRONIC DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A LEAK WAS NOT OBSERVED ANYWHERE ON THE DEVICE. THERE WAS NO DAMAGE TO THE DEVICE OR BALLOON. THE CUSTOMER STATED THAT THE ISSUE WAS THAT THE BALLOON DID NOT INFLATE ALL THE WAY. ONE END OF THE BALLOON WAS INFLATED ¾ AND THE OTHER END WAS INFLATED ¼. THE DOCTOR CHECKED 3 CANNULAE BEFORE INSERTING INTO TO THE PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER OBSERVED THE ISSUE WHEN PERFORMING THE WATER TEST. THE BALLOON WAS INFLATING ¾ FROM ONE CORNER AND ¼ FROM THE OTHER CORNER WHICH NORMALLY THE INFLATING SHOULD BE CENTRALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398352 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A GUNDRY SILICONE RCSP CANNULA WITH A MANUAL-INFLATE CUFF, THE BALLOON DID NOT INFLATE PROPERLY WHEN THE SURGEON ATTEMPTED TO USE THE CANNULA. THE DEVICE WAS REPLACED BY ANOTHER MEDTRONIC DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A LEAK WAS NOT OBSERVED ANYWHERE ON THE DEVICE. THERE WAS NO DAMAGE TO THE DEVICE OR BALLOON. THE CUSTOMER STATED THAT THE ISSUE WAS THAT THE BALLOON DID NOT INFLATE ALL THE WAY. ONE END OF THE BALLOON WAS INFLATED ¾ AND THE OTHER END WAS INFLATED ¼. THE DOCTOR CHECKED 3 CANNULAE BEFORE INSERTING INTO TO THE PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER OBSERVED THE ISSUE WHEN PERFORMING THE WATER TEST. THE BALLOON WAS INFLATING ¾ FROM 1 CORNER AND ¼ FROM THE OTHER CORNER WHICH NORMALLY THE INFLATING SHOULD BE CENTRALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398121 ↗
• MalfunctionNov 29, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A GUNDRY SILICONE RCSP CANNULA, THE CUSTOMER REPORTED THAT WHILE USING THE RETROGRADE CANULA AND TRYING TO INFLATE THE BALLOON, THERE WAS A LEAK AND THEY REALIZED THE BALLOON WAS RUPTURED. THE ISSUE HAPPENED FROM THE START. USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882640 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K860149. One submission often covers many models, so check the product and lot details in each record.

• Z-2215-2026 · Apr 21, 2026 · Open, Classified
  Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; 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-2218-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; 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-2216-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
• 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-2220-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; 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