GundryRecalls & reported problems across all models

We found 3 models of Gundry by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2021 and May 5, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (19 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Gundry recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. Apr 21, 2026Open, Classified

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

   Z-2214-2026 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Gundry problems

Gundry models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Gundry® 94113T

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall17 reports
• Gundry® 94115T

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall5 reports
• Gundry® 94715

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  5 reports

Recent Gundry adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054224 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054202 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054177 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054136 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054109 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054069 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054021 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053946 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053914 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053881 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053859 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053830 ↗
• MalfunctionJan 13, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE GUNDRY SILICONE RCSP CANNULAE WITH A MANUAL-INFLATE CUFF, IT WAS REPORTED THAT THE PACKAGES WERE NOT FULLY SEALED AND OPEN TO NORMAL AIR. THE CUSTOMER STATED THAT THE DEVICES WERE NOT STERILE. THE DEVICES WERE REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053785 ↗

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