TYRX™ CMRM6133 (UDI 00643169935907)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169935907), received between Mar 12, 2018 and Mar 11, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Expiration Issue” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2019Adverse 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 WITH AN ABSORBABLE ENVELOPE EXPERIENCED INFECTION AND WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8409131 ↗
• MalfunctionMar 16, 2018Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THE ABSORB-ABLE ANTIBACTERIAL ENVELOPE WAS IMPLANTED PAST THE EXPIRATION DATE. THE ENVELOPE REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7345411 ↗
• MalfunctionMar 14, 2018Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THAT AN ANTIBACTERIAL ENVELOPE WAS IMPLANTED AFTER THE USE-BY-DATE. THE ANTIBACTERIAL ENVELOPE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339733 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NOTED THE PATIENT EXPERIENCED AND INFECTION APPROXIMATELY THREE WEEKS AFTER THE IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) AND ABSORBABLE ENVELOPE. ANTIBIOTIC TREATMENT WAS PERFORMED. THE PATIENT HAD A KNOWN DRUG ALLERGY TO DOXYCYCLINE. THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7332458 ↗