Gundry® 94115TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20643169454525), received between May 12, 2023 and May 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

8 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Certain lots of product have the potential for a sterile barrier breach.

   Z-2215-2026 · Root cause: Packaging process control · FDA record ↗

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.

• MalfunctionMay 5, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT AT AN UNSPECIFIED TIME GUNDRY SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF THE STERILITY MAY HAVE BEEN COMPROMISED. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078968 ↗
• MalfunctionMay 5, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT AT AN UNSPECIFIED TIME GUNDRY SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF THE STERILITY MAY HAVE BEEN COMPROMISED. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078916 ↗
• MalfunctionDec 30, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A GUNDRY SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF, IT WAS REPORTED THAT IT COULD NOT BE INFLATED PROPERLY. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919781 ↗
• MalfunctionSep 4, 2025Burst Container or Vessel; Fluid/Blood Leak; Inflation Problem; Material Deformation; Burst Container or Vessel; Fluid/Blood Leak; Inflation Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A GUNDRY SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF, IT WAS REPORTED THAT DURING INFLATION, THE BALLOON RUPTURED ABNORMALLY. 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 22961172 ↗
• MalfunctionMay 12, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED A CRACK IN THE GUNDRY SILICONE CANNULA WITH MANUAL-INFLATE CUFF. THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919050 ↗

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-2217-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; 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-2219-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; 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-2218-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; 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-2216-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter