Attain Command™ + SureValve™ 6250V-45S (UDI 00643169143265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169143265), received between Jan 15, 2020 and Jan 15, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE HOUR POST IMPLANT AND ATRIOVENTRICULAR NODE ABLATION RESULTING IN AN UNDERLYING JUNCTIONAL RHYTHM, THE PATIENT EXPERIENCED RUNS OF VENTRICULAR TACHYCARDIA (VT) AND A SUSTAINED TORSADE'S EPISODE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING THRESHOLDS. THE NEXT MORNING THE RV LEAD DISPLAYED UNDERSENSING, WITH HIGH AND UNSTABLE THRESHOLDS AND A MICRO-DISLODGEMENT. AN RV LEAD REVISION WAS PLANNED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS NO LONGER FUNCTIONING AND HAD DISLODGED INTO THE RV. THE RV WAS REVISED TO A NEW LOCATION, REMAINS IN USE, AND HAD MEASUREMENTS ALL WITHIN NORMAL RANGES. THE LV LEAD WAS REMOVED AND WHEN THE PHYSICIAN ATTEMPTED TO REGAIN ACCESS TO THE CORONARY SINUS, THE DELIVERY CATHETER PERFORATED AND "MADE ITS OWN TRACK." AN ECHOCARDIOGRAM WAS PERFORMED AN NOTED A SMALL PERICARDIAL EFFUSION. THE LV LEAD REPLACEMENT WAS ABANDONED AND THE DEVICE WAS DOWNGRADED. THE PATIENT WAS ADMINISTERED ALBUMIN AND NO FURTHER INTERVENTION WAS NEEDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 9593726 ↗