PLATINIUM VR 1210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08031527015514), received between Aug 8, 2019 and Dec 11, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

4 other recalls cover devices cleared under the same FDA submission (P980049); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTEDLY, ON (B)(6) 2020, THE SUBJECT ICD WAS REPLACED AS IT WAS MALFUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10993357 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, ON (B)(6)2019 , THE SUBJECT ICD WAS EXPLANTED DUE TO A POCKET INFECTION. PRELIMINARY ANALYSIS REVEALED THAT THE SUBJECT DEVICE HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES.

  Patient problems: Unspecified Infection

  MAUDE report 8874326 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980049. One submission often covers many models, so check the product and lot details in each record.

• Z-3231-2017 · Jul 24, 2017 · Terminated
  Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single
• Z-3228-2017 · Jul 24, 2017 · Terminated
  Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single cham
• Z-3232-2017 · Jul 24, 2017 · Terminated
  Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single
• Z-3229-2017 · Jul 24, 2017 · Terminated
  Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single cham