TYRX™ CMRM6133 (UDI 00763000307882)Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 00763000307882), received between Jun 18, 2020 and Sep 30, 2026 — classified as 1 death, 118 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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, 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 128 reports, 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 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection; Wound Dehiscence

  MAUDE report 50828247 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND PURULENT DISCHARGE DUE TO A SYSTEMIC INFECTION AND EROSION. IT WAS ALSO NOTED THAT AN ABSORBABLE ENVELOPE WAS USED DURING THE IMPLANT. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 24278292 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT JUST OVER TWO WEEKS POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM IMPLANT WITH ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT EXPERIENCED A POCKET INFECTION. THE ICD SYSTEM WAS EXPLANTED AND A REPLACEMENT SYSTEM WAS IMPLANTED FIVE DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 23572311 ↗
• InjuryOct 28, 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 EXPLANTED DUE TO THE PATIENT'S POCKET INFECTION. THE PATIENT HAD ALSO EXPERIENCED DISCOMFORT AND REDNESS. ADDITIONALLY, AN ABSORBABLE ANTIBACTERIAL ENVELOPE HAD BEEN IMPLANTED WITH THE SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Unspecified Infection

  MAUDE report 23404505 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Discomfort; Erythema; Unspecified Infection

  MAUDE report 23391657 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE WAS REVIEWED REGARDING ANTIBACTERIAL ABSORBABLE ENVELOPE HYPERSENSITIVITY. THE AUTHORS DESCRIBED A PATIENT WHO UNDERWENT THE IMPLANT OF AN EXTRAVASCULAR (EV) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WITH THE USE OF AN ANTIBACTERIAL ABSORBABLE ENVELOPE. DURING THE PROCEDURE, IT TOOK FOUR DIFFERENT SUBSTERNAL TUNNELING ATTEMPTS TO PLACE THE LEAD WITHOUT P-WAVE OVERSENSING WHICH LED TO A PROLONGED PROCEDURE TIME. APPROXIMATELY TWO WEEKS POST IMPLANT, THE PATIENT DEVELOPED A GENERALIZED RASH WHICH AFFECTED THEIR UPPER EXTREMITIES AND LIMBS. AMIODARONE WAS STOPPED AND THE RASH RESOLVED. FOUR WEEKS LATER, THE PATIENT DEVELOPED A PRURITIC RASH WHICH RESEMBLED ¿BUG BITES¿ DIRECTLY OVER THE DEVICE POCKET. THE PATIENT HAD NO FEVER, PAIN, AND NO SIGNS OF HEMATOMA, PURULENT DRAINAGE, OR DEVICE EROSION. THE RASH RESOLVED WITH TOPICAL OINTMENTS. OVER THE NEXT 2 WEEKS, THE PATIENT EXPERIENCED RECURRENT EPISODES OF LOCALIZED PRURITIC RASH OVER THE DEVICE POCKET, AND IT WAS SUSPECTED THAT THE PATIENT HAD AN ALLERGIC REACTION. PATCH TESTING WAS PERFORMED, AND THE RESULTS SHOWED A POSITIVE REACTION TO THE ANTIMICROBIAL AGENTS IN THE ANTIBACTERIAL ABSORBABLE ENVELOPE. TWELVE TO S

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Rash

  MAUDE report 23009880 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEARLY FOUR WEEKS POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH ANTIBACTERIAL ABSORBABLE ENVELOPE IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING DISCOMFORT AND REQUESTED THE ICD SYSTEM BE EXPLANTED. THE SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 22829661 ↗
• InjuryAug 15, 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 WITH PURULENT DISCHARGE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM INCLUDING THE EXPLANT OF TYRX ENVELOPE WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22813816 ↗
• 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 TWO MONTHS 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 22546926 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVEN MONTHS POST DEVICE CHANGEOUT INVOLVING AN ANTIBACTERIAL ABSORBABLE ENVELOPE, A PORTION OF THE LEAD WAS EXPOSED DUE TO THE WOUND VAC THE PATIENT HAD. THE PATIENT UNDERWENT A POCKET REVISION, AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED WITH A NEW DEVICE ON THE OTHER SIDE. THE EPICARDIAL LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Impaired Healing

  MAUDE report 22546916 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE AND A HALF MONTHS POST RIGHT SIDED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IMPLANT INVOLVING AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE SYSTEM WAS EXPLANTED DUE TO EROSION. A NEW LEFT SIDED CRT-D SYSTEM WAS IMPLANTED 3 DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 22546906 ↗
• 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 AND EROSION OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM INVOLVING A ANTIBACTERIAL ABSORBABLE ENVELOPE. THE CRTP SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22546900 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Erosion; Erythema; Unspecified Infection

  MAUDE report 22546896 ↗
• 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 FIVE MONTHS POST IMPLANT OF A COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE PATIENT UNDERWENT AN EXTENSIVE DEBRIDEMENT OF THE INFECTED POCKET AND CAPSULE REMOVAL. THE POCKET WAS RELOCATED TO A SUBMAMMARY SUBPECTORAL SPACE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22546892 ↗
• 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 TWO MONTHS POST IMPLANT OF A COMPETITOR PACING SYSTEM WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22546829 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM INVOLVING AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS EXPLANTED APPROXIMATELY THREE WEEKS POST IMPLANT DUE TO AN INFECTION. THE SYSTEM WAS REPLACED FIVE DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22546825 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM INVOLVING AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS REMOVED DUE TO POCKET INFECTION THE MONTH FOLLOWING IMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22546815 ↗