TYRX™ CMRM6122 (UDI 00763000307875)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00763000307875), received between Jul 13, 2020 and Sep 28, 2026 — classified as 1 death, 63 injuries.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED APPROXIMATELY ONE MONTH POST IMPLANT THAT THE PATIENT DEVELOPED A POCKET INFECTION POST HEMATOMA. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH AN LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE HEMATOMA WAS EVACUATED PRIOR TO INFECTION. IT WAS FURTHER REPORTED THAT AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS PLACED DURING THE IMPLANT PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24663676 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY ONE MONTH POST IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE PATIENT WAS HOSPITALIZED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23778861 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM THAT THE PATIENT DEVELOPED AN INFECTION. THERE WAS POCKET DEHISCENCE AND REDNESS ALSO. THE IPG SYSTEM WAS REMOVED. IT WAS FURTHER REPORTED THAT AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS IMPLANTED WITH THE IPG SYSTEM. THE ANTIBACTERIAL ABSORBABLE ENVELOPE WAS EXPLANTED POST INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection; Wound Dehiscence

  MAUDE report 23450566 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AROUND THE DEVICE POCKET AREA. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED EROSION, PURULENT DISCHARGE/PUS, AND REDNESS. THE ENTIRE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE IPG SYSTEM WAS IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Medical device site infection; Purulent Discharge

  MAUDE report 23379663 ↗
• InjuryOct 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT DEVELOPED A POCKET INFECTION. IT WAS FURTHER NOTED THAT THERE WAS WOUND DEHISCENCE AND PURULENT DISCHARGE. THE IPG SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23201461 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION, DISCOMFORT, FEVER, PAIN AND REDNESS TWO DAYS POST IMPLANT OF AN IMP LANTABLE PULSE GENERATOR (IPG) WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO CAPTURE, HIGH THRESHOLDS AND LOW IMPEDANCE. THE IPG SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22883523 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY ONE MONTH POST IMPLANT OF A COMPETITOR IMPLANTABLE PULSE GENERATOR (IPG) WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE PATIENT WAS HOSPITALIZED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22546918 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE WEEKS POST IMPLANT OF THE SYSTEM, THE PATIENT EXPERIENCED INFECTION POSSIBLY FROM INCISION CLOSURE ON SKIN GLUE RESULTING IN DISCOMFORT AND REDNESS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM INCLUDING AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS EXPLANTED AND REPLACED BY A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Unspecified Infection

  MAUDE report 22546908 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AND INFECTION TWO WEEKS POST IMPLANT. THE ORGANISM OF INFECTION WAS KLEBSIELLA PNEUMNIAE ENTERCOCOCCUS GROUP D. THE PATIENT ALSO EXPERIENCED EROSION, REDNESS AND WOUND DEHISCENCE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM INVOLVING AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Erosion; Erythema; Wound Dehiscence

  MAUDE report 22546904 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THREE MONTHS POST IMPLANT, THE ENTIRE ICD SYSTEM WAS EXPLANTED DUE TO INFECTION, DISCOMFORT, REDNESS, AND WOUND DEHISCENCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22546883 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY SIX AND A HALF MONTHS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE ENTIRE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22546820 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE AND THE PATIENT LATER EXPERIENCED AN INFECTION, FEVER AND BACTEREMIA. THE IPG SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Fever; Unspecified Infection

  MAUDE report 22546812 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT THE PATIENT EXPERIENCED POCKET INFECTION RESULTING IN SWELLING, EROSION, DISCOMFORT, REDNESS, SWELLING, PAIN, PURULENT DISCHARGE AND WOUND DEHISCENCE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM INVOLVING AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 22546803 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT, THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM IMPLANTED WITH A ANTIBACTERIAL ABSORBABLE ENVELOPE WAS EXPLANTED DUE TO A POCKET INFECTION AND REPLACED WITH A LEADLESS PACEMAKER. ADDITIONALLY, THE PATIENT EXPERIENCED REDNESS, SWELLING, AND WOUND DEHISCENCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection; Swelling/ Edema; Wound Dehiscence

  MAUDE report 22030223 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), WHICH HAD BEEN IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE THREE MONTHS PRIOR, HAD ERODED AND WAS VISIBLE OUTSIDE THE BODY. INFECTION WAS NOTED. THE DEVICE SYSTEM WAS EXPLANTED AND A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 21987323 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED APPROXIMATELY TWO AND A HALF MONTHS POST-GENERATOR REPLACEMENT PROCEDURE WITH USE OF AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE SKIN ABOVE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RED, PURPLE, SWOLLEN, PAINFUL, WARM TO THE TOUCH WITH POSSIBLE ABSCESS, WITH REDNESS EXTENDING AROUND THE DEVICE TOWARDS THE NECK, AND THE PATIENT HAD A FEVER. THE PATIENT WAS ADMITTED FOR ADMINISTRATION OF INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS TRANSFERRED TO A HIGHER CARE FACILITY THE FOLLOWING WEEK. THE SYSTEM WAS REMOVED DUE TO POCKET INFECTION. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abscess; Erythema; Fever; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 21866900 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM IMPLANT WITH AN ANTI BACTERIAL ABSORBABLE ENVELOPE, THE PATIENT WAS EXPERIENCING FEVER, PURULENT DISCHARGE, AND REDNESS DUE TO A POCKET INFECTION. THE CRT-P SYSTEM WAS EXPLANTED AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED. ADDITIONALLY, THE HIS LEAD WAS ATTEMPTED AND NOT USED DUE TO PATIENT ANATOMY AND THE LEAD WAS REPLACED WITH A NEW HIS LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Fever; Purulent Discharge; Unspecified Infection

  MAUDE report 21057055 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PURULENT DISCHARGE AND SWELLING AS A RESULT OF AN INFECTION APPROXIMATELY EIGHT WEEKS AFTER THE IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE CRT-D SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 20696106 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION TWO WEEKS POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGE OUT PROCEDURE. AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS USED DURING IMPLANT. IT WAS REPORT THAT THE PATIENT NOTICED BLEEDING AND OPENING AT THE INCISION SITE AND WAS ADMINISTERED ANTIBIOTICS. THE PATIENT THEN DEVELOPED A FEVER, HAD DISCOMFORT, AND WAS ADMITTED TO THE HOSPITAL WITH CONTINUED BLEEDING AND WOUND DEHISCENCE. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Fever; Unspecified Infection; Wound Dehiscence

  MAUDE report 20546740 ↗