Current Accel® DR (REF CD2215-36)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734502641), received between Jun 21, 2018 and Feb 28, 2019 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: No Information

  MAUDE report 8379569 ↗
• InjuryNov 26, 2018Insufficient Device Problem Information

  DEVICE EVALUATION IS BEING SUBMITTED RELATED TO MANUFACTURING REPORT NUMBER 2938836-2014-14696.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104461 ↗
• InjuryNov 26, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE DEPLETION. THE DEVICE WAS REMOVED AND REPLACED WITH A COMPETITOR DEVICE WHILE THE PATIENT, WHO LIVED IN (B)(6), WAS ABROAD IN (B)(6). THE PATIENT WAS REPORTED TO BE STABLE POST-PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8102357 ↗
• MalfunctionNov 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING FOLLOW-UP, INAPPROPRIATE AUTOMATIC MODE SWITCH EPISODES WERE OBSERVED. TECHNICAL SUPPORT WAS CONTACTED AND SUGGESTED REPROGRAMMING THE DEVICE TO RESOLVE THE ISSUE. THE REPROGRAMMING IS ANTICIPATED TO BE PERFORMED AT FOLLOW-UP. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8038553 ↗
• MalfunctionOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: No Information

  MAUDE report 8007497 ↗
• InjuryAug 31, 2018Break; Break

  IT WAS REPORTED THAT LEAD NOISE ISSUE AND IT WAS SUSPECTED THAT THE LEAD NOISE WAS DUE TO SET SCREW BEING DAMAGED OR LOOSE PRIOR TO THE PROCEDURE. PHYSICIAN WENT TO UNSCREW THE ATRIAL LEAD AND THE SET SCREW POPPED OUT. DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED BECAUSE A NEW BATTERY WAS NEEDED AS WELL. ATRIAL LEAD WAS CHRONIC AND REMAINED IN PLACE AND IMPLANTED WITH THE NEW IMPLANTED DEVICE. THERE WAS NO NOISE WITH THE NEW DEVICE. PATIENT WAS STABLE DURING THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838544 ↗
• InjuryJun 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED ON (B)(6) 2018. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7627904 ↗