Vega TLD041URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08031527019796), received between Feb 5, 2026 and Feb 5, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

1 other recall cover devices cleared under the same FDA submission (P130010, P950029); they may or may not involve this specific model.

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.

• MalfunctionFeb 5, 2026Unintended Movement

  PATIENT DEVELOPED PERICARDITIS SECONDARY TO A LATE LEAD PERFORATION. THE LEAD WAS POSITIONED IN THE RV AND WAS CONNECTED TO AN IMPULSE DYNAMICS OPTIMIZER SMART MINI GENERATOR. LEAD MEASUREMENTS AT IMPLANT WERE [email protected], 11MV, & 870OHMS. THE PATIENT ALSO HAS A BOSTON SCIENTIFIC S-ICD IMPLANTED.

  Patient problems: Cardiac Perforation; Pericarditis

  MAUDE report 24266185 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130010, P950029. One submission often covers many models, so check the product and lot details in each record.

• Z-2235-2009 · Sep 23, 2008 · Terminated
  Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14