ESSENZ RP150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04033817902997), received between Dec 12, 2023 and Mar 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K232291); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT ABOUT AN ESSENZ HLM THAT SHOWED THE ERROR MESSAGE ¿ART. PUMP ISSUE (2335)¿ RELATED TO THE ARTERIAL PUMP, AND THE PUMP BOX WAS RED WITH A WRENCH. THE ISSUE OCCURRED AFTER THE CASE WAS COMPLETED WITH NO PATIENT IMPACT. AFTER THE ERROR MESSAGE, THE PUMP STOPPED AND THE PERFUSIONIST TRIED TO INCREASE THE RPM OF THE PUMP, BUT IT WOULD NOT TURN. REPORTEDLY, THE PROBLEM WAS SOLVED BY RESTARTING THE HLM; AFTER THAT, THE PUMP WORKED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567235 ↗
• MalfunctionJan 22, 2026Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A ROLLER PUMP ASSEMBLED ONTO ESSENZ HEART-LUNG MACHINE (HLM) WHICH SUDDENLY STOPPED DURING PROCEDURE, FOLLOWED BY MULTIPLE ALARMS. CUSTOMER PERFORMED HAND-CRACK AND CONCLUDED THE CASE WITHOUT ANY FURTHER ISSUE. AFTER THE END OF THE PROCEDURE, THE UNIT WAS MANUALLY CHECKED AND THE ARTERIAL PUMP WAS FOUND PROPERLY FUNCTIONING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24142362 ↗
• MalfunctionNov 27, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797016 ↗
• MalfunctionDec 12, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PRCEDURE, THE ESSENZA RPD150 PUMP DISPLAYED ERROR INDICATING DEVIATION OF THE OBSERVED DIRECTION OF ROTATION FROM THE SET DIRECTION OF ROTATION (E2350) AND STOPPED. AFTER TURNING THE KNOB TO ZERO (0) AND BACK TO INITIAL FLOW THE PUMP STARTED AGAIN. PROCEDURE COULD BE FINISHED. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309614 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232291. One submission often covers many models, so check the product and lot details in each record.

• Z-0571-2025 · Oct 18, 2024 · Open, Classified
  Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software