HemoSphere HEMSGM10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103196993), received between Jan 5, 2023 and May 18, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 2, 2017Terminated

   Pre-procedural issues related to software defects

   Z-0496-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Patient Device Interaction Problem

  AS REPORTED FROM GERMANY BY OUR EDWARDS LIFESCIENCES AFFILIATES, HEART BLOCK OCCURRED POST IMPLANT OF A 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION BY RIGHT TRANSFEMORAL APPROACH. DURING IMPLANTATION, THE VALVE JUMPED IN LEFT VENTRICLE DIRECTION AND WAS IMPLANTED IN THE 50/50 (AORTIC: VENTRICULAR) POSITION. THE PATIENT HAD GOOD HEMODYNAMICS AND NO PARAVALVULAR LEAK. NO ACTION WAS NEEDED. THE POSITIONING PROBLEMS MAY HAVE OCCURRED DUE TO THE MASSIVE HYPERTROPHY OF LEFT VENTRICLE. AFTER THE IMPLANTATION, A THIRD-DEGREE HEART BLOCK OCCURRED, REQUIRING PACING WITH THE TEMPORARY PACEMAKER USED FOR IMPLANTATION. ADDITIONALLY, A PERMANENT PACEMAKER WAS REQUIRED ON THE SAME DAY AS THE PROCEDURE. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Heart Block

  MAUDE report 25204215 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE JAPANESE TAVI REGISTRY REPORTING SYSTEM, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND RECEIVED A 26MM SAPIEN 3 ULTRA RESILIA VALVE. ON POSTOPERATIVE DAY 6, CEREBRAL INFARCTION (CI) WAS OBSERVED.

  Patient problems: Stroke/CVA

  MAUDE report 24926453 ↗
• InjuryMar 31, 2026Perivalvular Leak; Malposition of Device

  AS REPORTED BY OUR GERMAN AFFILIATE DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 20MM SAPIEN 3 ULTRA VALVE, ALTHOUGH THE VALVE WAS APPROPRIATELY POSITIONED BETWEEN THE BALLOON MARKERS PRIOR TO DEPLOYMENT, DURING VALVE DEPLOYMENT THE 20MM COMMANDER DELIVERY SYSTEM (DS) BALLOON INFLATED UNEXPECTEDLY, WITH THE PROXIMAL (OUTFLOW) PORTION INFLATING FIRST WHILE THE DISTAL (INFLOW) PORTION REMAINED SNARED WITH THE VALVE AND THEN ABRUPTLY INFLATING WITH THE PROXIMAL BALLOON PART, CAUSING AN UNPREDICTABLE VALVE DEPLOYMENT. CONSEQUENTLY, THE VALVE WAS IMPLANTED TOO HIGH IN THE AORTIC POSITION, WITH A HIGHER GRADE OF PARAVALVULAR LEAK OBSERVED ON FINAL FLUOROSCOPY. THE DELIVERY SYSTEM WAS SUBSEQUENTLY REMOVED WITHOUT ANY ISSUES, AND NO DAMAGE WAS OBSERVED ON THE 14FR ESHEATH+ UPON WITHDRAWAL. A SECOND VALVE WAS THEN IMPLANTED MORE VENTRICULAR WHICH RESULTED IN NO PARAVALVULAR LEAK. THE PROCEDURE WAS THEREFORE COMPLETED SUCCESSFULLY. NO INJURY WAS REPORTED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Insufficient Information

  MAUDE report 24744942 ↗
• MalfunctionApr 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED DURING USE THE HEMOSPHERE SWAN GANZ MODULE WAS GIVING INCORRECT VALUES. A NEW MODULE WORKED AS EXPECTED. NO DAMAGE WAS NOTED. THERE WAS NO ADDITIONAL INFORMATION. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935630 ↗
• MalfunctionJan 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE SWAN GANZ MODULE DURING PATIENT MONITORING. THERE WERE INCONSISTENT CO/CI READINGS. THEY EXCHANGED FOR DIFFERENT SWAN CATHETERS AND IT DID NOT RESOLVE THE ISSUE. THEY EXCHANGED THE SG MODULE FOR TROUBLESHOOTING. THERE WERE NO ERROR MESSAGES DISPLAYED. THERE IS NO PHYSICAL DAMAGE APPARENT. THE EDWARDS FIELD REPRESENTATIVE HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION, BUT HAS NOT BEEN SUCCESSFUL. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT DEMOGRAPHIC INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108715 ↗