Paradym RF DR 9550Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08031527012254), received between Apr 25, 2017 and Apr 30, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  REPORTEDLY, THE RECOMMENDED REPLACEMENT TIME (RRT) WAS REACHED EARLIER THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753704 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, AN INFECTION RELATIVE TO THE SUBJECT DEVICE OCCURRED. THE DEVICE WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 11295696 ↗
• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, ON (B)(6) 2020, THE DEFIBRILLATION SYSTEM WAS EXPLANTED DUE TO AN INFECTION. PRELIMINARY ANALYSIS SHOWED THAT THE SUBJECT DEVICE WAS STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE STANDARD OPERATING PROCEDURES.

  Patient problems: Unspecified Infection

  MAUDE report 10707549 ↗
• InjuryJul 20, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Low impedance

  REPORTEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER HAVING RECEIVED SEVERAL INAPPROPRIATE SHOCKS BOTH AT HOME AND AT THE HOSPITAL. A MAGNET WAS APPLIED ON THE ICD UNTIL A COMPANY REPRESENTATIVE COULD INTERROGATE THE ICD. DEVICE INTERROGATION REVEALED THAT VENTRICULAR COIL CONTINUITY MEASUREMENTS WERE BELOW 200 OHMS. SINCE (B)(6) 2020, NON-PHYSIOLOGICAL SIGNALS WITH FAST RHYTHM WERE OBSERVED ON THE VENTRICULAR CHANNEL, LEADING TO THE DELIVERY OF INAPPROPRIATE THERAPIES SINCE (B)(6) 2020. THOUGH THE RIGHT LEAD IMPEDANCE CURVE WAS RELATIVELY STABLE, PUNCTUAL VARIATIONS OF MORE THAN 200 OHMS WERE NOTED SINCE (B)(6) 2020. CONSEQUENTLY, IT WAS DECIDED TO TURN OFF THE THERAPIES. A REVISION OF THE DEFIBRILLATION SYSTEM AND ITS REPLACEMENT WERE PERFORMED ON (B)(6) 2020, AS THE CONSECUTIVE SHOCK DELIVERIES COULD HAVE INDUCED A DECREASE OF THE BATTERY LONGEVITY. PRELIMINARY ANALYSIS REVEALED THAT THE INAPPROPRIATE SHOCKS DELIVERED ON (B)(6) 2020 MOST PROBABLY RESULTED FROM A VENTRICULAR LEAD ISSUE.

  Patient problems: No Information

  MAUDE report 10295421 ↗
• InjuryOct 2, 2018Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  REPORTEDLY, UPON INTERROGATION OF THE DEVICE, MULTIPLE WARNING MESSAGES WERE DISPLAYED INCLUDING: [27] THE DEVICE WAS REINITIALIZED 1 TIME SINCE THE BEGINNING OF LIFE, [59] RESET OCCURRED ON (B)(6) 2018, [A1] LOW SHOCK IMPEDANCE ON (B)(6) 2018 AND [A4] MAX SHOCK ENERGY INEFFECTIVE ON (B)(6) 2018. THE PATIENT IS HOSPITALIZED AND REPORTEDLY MAY HAVE BEEN EXPERIENCING RUNS OF VT AND MAY HAVE BEEN RECEIVING SHOCKS. IT IS ALSO POSSIBLE THE PATIENT WAS EXTERNALLY CARDIOVERTED HOWEVER, THIS WAS NOT CONFIMED. PRELIMINARY ANALYSIS REVEALED THAT OVERLOAD CONDITIONS WERE MET ON (B)(6) 2018. AND CONFIRMED THAT THE RESET OCCURRED. THIS RESET WAS RELATED TO THE DETECTION OF CORRUPTED DATA IN THE DEVICE MEMORIES.

  Patient problems: No Information

  MAUDE report 7925078 ↗
• InjuryDec 4, 2017Over-Sensing; Over-Sensing

  REPORTEDLY, DURING A FOLLOW-UP PERFORMED (B)(6) 2017, EPISODES STORED IN THE DEVICE MEMORIES WERE SUSPICIOUS OF VENTRICULAR OVERSENSING.

  Patient problems: No Information

  MAUDE report 7079312 ↗
• InjuryJun 1, 2017Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE AND THE ASSOCIATED LEADS WERE REMOVED DUE TO BLOOD INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6605318 ↗
• InjuryMay 17, 2017Contamination /Decontamination Problem; Contamination /Decontamination Problem

  REPORTEDLY, THE DEFIBRILLATION SYSTEM WAS EXPLANTED DUE TO INFECTION. THE SUBJECT DEVICE WILL BE RETURNED FOR ANALYSIS. AN INVESTIGATION IS REQUIRED. PRELIMINARY ANALYSIS SHOWED THAT THE DEVICE HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES.

  Patient problems: Unspecified Infection

  MAUDE report 6571898 ↗
• InjuryApr 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE SUBJECT ICD WAS EXPLANTED WITH LEADS DUE TO DUE TO COMPLICATIONS. IT WAS MENTIONED ALSO 'DEFECTIVE LEAD'. THE SUBJECT ICD WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6519045 ↗

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-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
• 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