ATTAIN STARFIX™ 419588Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169590649), received between Dec 9, 2016 and May 27, 2021 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (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.

• InjuryMay 27, 2021Adverse 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 WAS REMOVED DUE TO INFECTION. THE LEFT VENTRICULAR (LV) LEAD WAS PARTIALLY REMOVED WITH THE REMAINDER BEING CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11897591 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEADS WERE EXPLANTED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10582257 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POCKET INFECTION. ANTIBIOTIC TREATMENT WAS NECESSARY. THE DEVICE AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8279319 ↗
• MalfunctionJan 23, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS UNDERSENSING DURING RECORDED ARRHYTHMIA EPISODES. THE LEFT VENTRICULAR (LV) LEAD HAD TRIGGERED A WARNING FOR OUT-OF-RANGE PACING IMPEDANCE WHICH WAS CURRENTLY NOTED TO BE LOW. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8271418 ↗
• MalfunctionApr 25, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SUTURE SLEEVE ON THE ATTEMPTED LEFT VENTRICULAR (LV) LEAD BROKE IN HALF AFTER BEING TIED BY THE PHYSICIAN. THE LEAD WAS REMOVED AND A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7462094 ↗
• InjuryAug 9, 2017Adverse 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 WAS EXPLANTED DUE TO DEVICE POCKET WOUND DEHISCENCE. THE DEVICE SYSTEM WILL BE REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 6781934 ↗
• InjuryDec 9, 2016Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT DURING A DEVICE FOLLOW-UP, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE, ALONG WITH A HIGH LV PACING THRESHOLD. THE LV LEAD WAS EXPLANTED AND REPLACED WITH AN EPICARDIAL LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6162439 ↗