Gundry® 94113TRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 20643169454877), received between Jan 13, 2026 and Jan 13, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (17 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-2214-2026 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 24053633 ↗
• 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 24053590 ↗
• 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 24053577 ↗
• 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 24053547 ↗

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-2218-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
• Z-2215-2026 · Apr 21, 2026 · Open, Classified
  Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; 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-2221-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; 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-2216-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; 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-2217-2026 · Apr 21, 2026 · Open, Classified
  Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter