TYRXRecalls & reported problems across all models

We found 11 models of TYRX by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 303 adverse event reports in the FDA's MAUDE database, received between Mar 12, 2018 and Sep 30, 2026 — classified as 2 deaths, 275 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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. 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

Most reported TYRX problems

TYRX models

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

• TYRX™ CMRM6133

  Mesh, surgical, polymeric
  1 death128 reports
• TYRX™ CMRM6122

  Mesh, surgical, polymeric
  1 death64 reports
• TYRX™ CMRM6133

  Mesh, surgical, polymeric
  52 reports
• TYRX™ CMRM6122

  Mesh, surgical, polymeric
  17 reports
• TYRX™ NMRM6122

  Mesh, surgical, polymeric
  14 reports
• TYRX™ NMRM6122

  Mesh, surgical, polymeric
  9 reports
• TYRX™ CMRM6122

  Mesh, surgical, polymeric
  8 reports
• TYRX™ NMRM6133

  Mesh, surgical, polymeric
  5 reports
• TYRX™ CMRM6133

  Mesh, surgical, polymeric
  4 reports
• TYRX™ NMRM6133

  Mesh, surgical, polymeric
  1 report
• TYRX™ NMRM6133

  Mesh, surgical, polymeric
  1 report

Recent TYRX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Medical device site infection

  MAUDE report 50949711 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had a competitor device implanted with an antibacterial absorbable envelope. Approximately one and a half months post implant, the patient had experienced discomfort, pain, swelling and had redness at the implant site. It was further reported that the implant pocket site was intermittently red, hot to touch and itchy. It was stated that it was suspected that the patient had pocket infection. The antibacterial absorbable envelope remained in the patient. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erythema; Itching Sensation; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 50921000 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection; Wound Dehiscence

  MAUDE report 50828247 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection approximately three months post-antibacterial absorbable envelope implant. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50526030 ↗
• InjuryAug 24, 2026Appropriate Device Problem Term/Code Not Available

  It was reported one day after implant that the Right Atrial (RA) lead exhibited dislodgement, high impedance and polarity switch. The Right Ventricular (RV) lead exhibited high impedance, polarity switch, and oversensing. The RA lead was repositioned and the RV lead remained in use. It was further reported five days after implant that the patient experienced an infection. The Implantable Pulse Generator (IPG) system and antibacterial absorbable envelope were explanted seven days after implant. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50402902 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that less than six months post implant of a Cardiac Resynchronization Therapy Pacemaker (CRT-P) system with an antibacterial absorbable envelope, the patient experienced a Methicillin-resistant Staphylococcus aureus bacteremia infection with aortic valve vegetation and pneumonia. The CRT-P system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Pneumonia

  MAUDE report 50083726 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately three months post-implant with an antibacterial absorbable envelope, the Cardiac Resynchronization Therapy Defibrillator (CRT-D) device system was explanted due to a pocket infection. A pacemaker system was implanted several days later. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50078290 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT PROCEDURE OF THE DEVICE AND AN ABSORBABLE ANTIBACTERIAL ENVELOPE, THE PATIENT DEVELOPED CLEAR FLUID THAT WAS DRAINING FROM THE PROCEDURE INCISION. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A FEVER. ANTIBIOTICS WERE ADMINISTERED. IT WAS FURTHER REPORTED THAT THERE WAS A SMALL WOUND DEHISCENCE NOTED, STERI STRIPS WERE APPLIED TO THE WOUND. IT WAS NOTED THAT THERE WERE NO SIGNS OF AN INFECTION AND THE ANTIBIOTICS WERE PROPHYLACTIC. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM AND ANTIBACTERIAL ABSORBABLE ENVELOPE REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 25597604 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION APPROXIMATELY THREE WEEKS POST IMPLANT WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT, PAIN, REDNESS AND WOUND DEHISCENCE. THE SYSTEM WAS EXPLANTED WITH NO REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 25577412 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION, EROSION AND POCKET DEHISCENCE. ITS REPORTED THAT THE ORGANISM OF INFECTION WAS STREP INTERMEDIUS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS PLACED DURING THE IMPLANT PROCEDURE.

  Patient problems: Erosion; Medical device site infection; Wound Dehiscence

  MAUDE report 24793648 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY ONE MONTH POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM THAT THE PATIENT DEVELOPED A POCKET INFECTION. IT WAS NOTED THE PATIENT EXPERIENCED PURULENT DISCHARGE, REDNESS, SWELLING AND WOUND DEHISCENCE. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS PLACED DURING THE IMPLANT PROCEDURE.

  Patient problems: Drug Resistant Bacterial Infection; Erythema; Inflammation; Medical device site infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 24729176 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST POCKET REVISION PROCEDURE AND ANTIBACTERIAL ABSORBABLE ENVELOPE IMPLANT, THE PATIENT EXPERIENCED POCKET EROSION WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTIVE ENDOCARDITIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, THE SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Endocarditis; Pocket Erosion

  MAUDE report 24706523 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ABOUT A MONTH AFTER THE IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM THE PATIENT HAD A POCKET INFECTION WITH DISCOMFORT, PAIN, REDNESS AND SWELLING. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING THE IMPLANT PROCEDURE AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS PLACED.

  Patient problems: Discomfort; Erythema; Inflammation; Medical device site infection; Pain

  MAUDE report 24702275 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 12 WEEKS POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR ( CRT-D) UPGRADE, THERE WAS A POCKET INFECTION WITH WOUND DEHISCENCE AND PURULENT DISCHARGE/PUS. THE CRT-D SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS PLACED DURING THE IMPLANT PROCEDURE.

  Patient problems: Medical device site infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 24681893 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST OPERATIVE THE PATIENT EXPERIENCED EROSION, PURULENT DISCHARGE, REDNESS AND AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS PLACED DURING THE IMPLANT PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24669632 ↗

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