PLATINIUM DR 1510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08031527015521), received between Feb 9, 2017 and Feb 23, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT ICD AND THE TWO (SORIN) ASSOCIATED LEADS WERE IMPLANTED ON (B)(6) 2017. REPORTEDLY, THE DEFIBRILLATION SYSTEM WAS EXPLANTED ON (B)(6) 2018 DUE TO AN INFECTION. PRELIMINARY ANALYSIS REVEALED THAT THE ICD HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES.

  Patient problems: Unspecified Infection

  MAUDE report 7291695 ↗
• InjuryJun 30, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DURING A ROUTINE FOLLOW-UP OF A PLATINIUM DR 1510 SN (B)(4) ON (B)(6) 2017, WARNING MESSAGE ¿62 EXCESSIVE CHARGE TIME DETECTED. DEFIBRILLATION SYSTEM POTENTIALLY INEFFECTIVE.¿ WAS DISPLAYED AT INTERROGATION. REPORTER WANTS TO KNOW WHY THIS MESSAGE WAS DISPLAYED AND WHAT THIS INDICATED. THE LAST CHARGE TIME DISPLAYED ON THE OVERVIEW SCREEN WAS 9.8 SECONDS. NO DETECTION LISTED FOR THIS DEVICE. THE LAST CHARGE TO 42 J WAS LISTED AS BEING ON THE DAY OF IMPLANT, (B)(6) 2017. A REAL TIME CHARGE TIME TEST TO 42 JOULES WITH A CHARGE TIME OF 10 SECONDS AND DURATION OF 16 SECONDS WAS CONDUCTED. THIS CHARGE TIME TEST APPEARED TO BE NORMAL. ALL OTHER FOLLOW-UP TESTS WERE NORMAL FOR THIS DEVICE. PRELIMINARY ANALYSIS SHOWED THAT THE REPORTED WARNING WAS DISPLAYED DUE TO AN INCOMPLETE CHARGE THAT OCCURRED BEFORE IMPLANTATION, WHEREAS THE WHOLE SYSTEM WAS PROBABLY NOT IN PLACE. CHARGE TIME UPON IMPLANTATION WAS CORRECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6680486 ↗
• InjuryFeb 9, 2017Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  ON (B)(6) 2017, EPISODES WITH OVERSENSING AND QUESTIONABLE SHOCK THERAPY DELIVERY WERE REPORTED. REVIEW OF THE EPISODES STORED IN THE DEVICE MEMORY REPORTEDLY REVEALED THE LIKELIHOOD FOR AV CROSSTALK (A ACTIVITY SENSED ON V CHANNEL). THERE WAS SUSPECTED COMPLICATIONS WITH THE POSITION OF BOTH LEADS. AN ANALYSIS IS REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6315351 ↗

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-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
• 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