MRI SeedNet®Gold Console FPRCH2033Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290104830914), received between Feb 27, 2020 and May 29, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, IN A LITERATURE ARTICLE, THREE PROSTATE CANCER PATIENTS TREATED WITH CRYOABLATION WITH MRI-SEEDNET (GALIL MEDICAL) EXPERIENCED SERIOUS ADVERSE EVENTS OF URETHRAL STRICTURE, MYOCARDIAL INFARCTION AND PROSTATE SWELLING. THE LITERATURE PAPER TITLED: "FOCAL SALVAGE MR IMAGING GUIDED CRYOABLATION FOR LOCALIZED PROSTATE CANCER RECURRENCE AFTER RADIOTHERAPY: 12-MONTH FOLLOW-UP" BY BOMERS ET. AL. DESCRIBES A RETROSPECTIVE, SINGLE-CENTRE REVIEW OF 62 PATIENTS WITH PROSTATE CANCER TREATED WITH MR-GUIDED CRYOABLATION. ADVERSE EVENTS WERE CLASSIFIED ACCORDING TO THE CLAVIEN AND SIR CLASSIFICATION SYSTEM. THE ARTICLE DESCRIBED THE FOLLOWING ADVERSE EVENTS: ONE PATIENT DEVELOPED A URETHRAL STRICTURE 6 MONTHS LATER, WHICH WAS SURGICALLY TREATED (CLAVIEN GRADE 3B, SIR CLASS C). ANOTHER PATIENT WAS HOSPITALIZED FOR 17 DAYS BECAUSE THEY EXPERIENCED A MYOCARDIAL INFARCTION THE DAY AFTER THE CRYOABLATION. ALTHOUGH IT IS NOT CLEAR THAT THE MYOCARDIAL INFARCTION WAS RELATED TO THE CRYOABLATION PROCEDURE, IT WAS DEFINED AS A CLAVIEN GRADE 4A/SIR CLASS D COMPLICATION. EIGHT OTHER PATIENTS HAD ACUTE URINARY RETENTION. IN THE EIGHT PATIENT, PLACEMENT OF AFOLEY CATHETER WAS NOT POSSIBLE

  Patient problems: Myocardial Infarction; Swelling; Urinary Retention

  MAUDE report 10101330 ↗
• MalfunctionFeb 27, 2020Difficult or Delayed Activation; Activation Problem; Difficult or Delayed Activation; Activation Problem

  4 NEEDLES WERE USED IN A MRI GUIDED RENAL CRYOABLATION PROCEDURE. DURING THE CASE, ALL 4 ICEROD MRI NEEDLES ONLY REACHED AN ICEBALL SIZE OF APPROX. 1 CM, WHICH WAS INSUFFICIENT FOR THE PROCEDURE. EXTRA ACTIVE THAWING CYCLES DID NOT RESOLVE THIS. MULTIPLE FREEZING CYCLES WERE CONDUCTED IN AN ATTEMPT TO REACH AN ACCEPTABLE ABLATION ZONE. THE TREATMENT WAS DEEMED UNSUCCESSFUL, AND A NEW CRYOABLATION PROCEDURE HAS BEEN SCHEDULED FOR THIS PATIENT. ALL FOUR NEEDLES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION, AND THE CRYOABLATION SYSTEM WAS INVESTIGATED IN A FIELD SERVICE CALL. THIS MDR SUMMARISES THE INVESTIGATION RESULTS OF THE CRYOABLATION SYSTEM USED IN THIS COMPLAINT. PLEASE SEE THE FOLLOWING MDR'S FOR THE OTHER DEVICES USED DURING THIS CRYOABLATION PROCEDURE: 9616793-2020-00035 - NEEDLE 1, 9616793-2020-00036 - NEEDLE 2, 9616793-2020-00037 - NEEDLE 3, 9616793-2020-00038 - NEEDLE 4.

  Patient problems: No Code Available

  MAUDE report 9766520 ↗