CPR4 B10031Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08031527019611), received between Oct 16, 2025 and Sep 25, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894383 ↗
• MalfunctionSep 17, 2026Crack

  Reportedly, head installed as a replacement for RA2211068, which has cracks on two of the three corners with mounting points.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803225 ↗
• MalfunctionSep 17, 2026Crack

  Increased cracking at the corners around the attachment points, along with a malfunction of one of the four white LEDs.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802851 ↗
• MalfunctionSep 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50606210 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50537848 ↗
• MalfunctionAug 28, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497385 ↗
• MalfunctionAug 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192929 ↗
• MalfunctionJun 17, 2026Crack

  REPORTEDLY, ON (B)(6) 2026, THE CPR4 HEAD HAS SOME CRACKS ON THE EDGES, BUT IS STILL WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25532857 ↗
• MalfunctionJun 17, 2026Communication or Transmission Problem

  REPORTEDLY, THE SUBJECT CPR4 IS NOT RECOGNISED BY SEVERAL TABLETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528845 ↗
• MalfunctionMay 21, 2026Telemetry Discrepancy

  REPORTEDLY, ON (B)(6) 2026, IT WAS IMPOSSIBLE TO INTERROGATE AN ALIZEA IMPLANT. CPR4 HEAD LED DID NOT LIGHT ON. INTERROGATION WAS RETRIED WITH ANOTHER ALIZEA IMPLANT AND IT DID NOT WORK, IT WAS ALSO RETRIED WITH AN ENO IMPLANT AND IT WORKED. ANOTHER PROGRAMMER WAS USED TO INTERROGATE ALIZEA IMPLANT AND IT WORKED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240872 ↗
• MalfunctionFeb 26, 2026Communication or Transmission Problem

  REPORTEDLY, ON 28-JANUARY-2026, INTERROGATION ISSUE OCCURRED. ON/OFF TABLET BUTTON IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452447 ↗
• MalfunctionFeb 5, 2026Telemetry Discrepancy

  REPORTEDLY, ON 8-JANUARY-2026, THE CPR4 HEAD IS UNUSABLE TO INTERROGATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268616 ↗
• MalfunctionDec 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTEDLY, ON 11-DECEMBER-2025, THE CPR4 HEAD LED ARE OUT OF ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933404 ↗
• MalfunctionDec 19, 2025Communication or Transmission Problem; Communication or Transmission Problem

  REPORTEDLY, ON (B)(6) 2025, THE BLUETOOTH IS LOST DURING IMPLANTATION OF ALIZEA DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847447 ↗
• MalfunctionDec 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTEDLY, ON (B)(6) 2025, INTERROGATION OF A DEVICE BEFORE MRI IS IMPOSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825436 ↗
• MalfunctionNov 27, 2025Activation Failure; Activation Failure

  REPORTEDLY, ON (B)(6) 2025, AFTER 1 MONTH OF USE CPR4 STOPPED WORKING. NO PHYSICAL SIGN OF BAD USAGE. HCP STATED THAT IT STARTED TO FAIL, BUT MOVING THE CABLE THEY MANAGE TO USE IT. NOW IT STOPPED BEING RECOGNISED COMPLETLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665883 ↗
• MalfunctionNov 7, 2025Communication or Transmission Problem; Communication or Transmission Problem

  REPORTEDLY, ON (B)(6) 2025, IT IS DIFFICULT TO INTERROGATE DEVICES WITH THE CPR4 HEAD (EVEN WITH CHANGING USB PORT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23495723 ↗
• MalfunctionNov 6, 2025Telemetry Discrepancy; Telemetry Discrepancy

  REPORTEDLY, THE CPR4 IS NOT RECOGNISED BY THE SMARTTOUCH TABLET. THERER ARE DAMAGES ON THE PLASTURGY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484326 ↗
• MalfunctionNov 6, 2025Intermittent Continuity; Intermittent Continuity

  REPORTEDLY, DURING FOLLOW-UPS, THE COMMUNICATION BETWEEN THE PROGRAMMER AND THE IMPLANTABLE DEVICE WAS INTERRUPTED SEVERAL TIMES DESPITE A GOOD POSITIONING OF THE PROGRAMMING HEAD ON THE IMPLANTABLE DEVICE. THE CABLE IS BENT AT THE LEVEL OF THE USB CONNECTOR AND THIS MAY TRIGGER A BAD ELECTRICAL CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484253 ↗
• MalfunctionNov 3, 2025Break; Break

  REPORTEDLY, THE SUBJECT PROGRAMMING HEAD CPR4 IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451753 ↗
• MalfunctionOct 31, 2025Telemetry Discrepancy; Telemetry Discrepancy

  REPORTEDLY, ON (B)(6) 2025, THE CPR4 HEAD IS OUT OF ORDER. IT DOES NOT CONNECT TO PROGRAMMERS AND THERE IS NO LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435724 ↗
• MalfunctionOct 16, 2025Communication or Transmission Problem; Communication or Transmission Problem

  REPORTEDLY, ON (B)(6) 2025, IT WAS IMPOSSIBLE TO INTERROGATE PATIENT DEVICE. AN ERROR MESSAGE IS DISPLAY. REBOOTING THE TABLET SEVERAL TIMES DID NOT RESOLVE THE ISSUE. REPLACING THE PROGRAMMER AND PROGRAMMING HEAD RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307958 ↗

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-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
• 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