WEBSTER D6FR252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835004502), received between Jul 29, 2026 and Jul 29, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryJul 29, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an ablation procedure with a WEBSTER Catheter and experienced a cardiac tamponade which required pericardiocentesis.After procedure, patient was alert and oriented during groin access closure, but just after, the patient dropped their blood pressure to 50/20 and became non-responsive. Doctor used an ultrasound machine and checked with a probe on the patient¿s chest for a pericardial effusion. The patient did have one, therefore, the doctor performed a pericardiocentesis on the patient and a total of 400cc came out. Patient was stabilized, woke up and blood pressure was 152/73 on no medications. Extended hospitalization was required as the patient spent the night in the intensive care unit. Patient fully recovered. Blood pressure stabilized and she became alert and orientated again. She just has pain in her chest where the drain is. Doctor believes Biosense quad catheter perforated the right ventricle.Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available.

  Patient problems: Cardiac Tamponade

  MAUDE report 50077585 ↗