CardioGenesis HP-SG3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00877234000102), received between Sep 22, 2015 and Apr 24, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Calibration Error” (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. How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2018Difficult to Advance; Difficult to Advance

  PER THE INITIAL REPORT, "[COMPLAINANT] CALLED TO LET ME KNOW THAT [SURGEON] HAD TWO (2) SOLOGRIP III HANDPIECES THAT WHERE NOT FUNCTIONING PROPERLY. HE WAS NOT IN THE CASE, BUT TEXTED ME THE NUMBER OF [NURSE] WHOM WAS SCRUBBED INTO [SURGEON]'S CASE. THIS SURGICAL TEAM IS VERY EXPERIENCED WITH THE CARDIOGENESIS TMR LASER PROCEDURE AND PRODUCTS. I CALL [NURSE] TO DISCUSS THE CASE. SHE SAID THEY OPENED THE FIRST SOLOGRIP III AND SHE SAID THAT "THE DEVICE DID NOT LOOK NORMAL AND THE "CABLE WAS NOT CONNECTED TO THE "BUBBLE" OF THE DEVICE." THEY IMMEDIATELY OPENED A SECOND SOLOGRIP III HANDPIECE, BUT [SURGEON] AND [NURSE] TRIED, BUT COULD NOT MAKE THE LASER CHANNEL MECHANISM TO RETRACT. A THIRD SOLOGRIP III WAS OPENED AND WORKED AS IT SHOULD AND WAS USED IN THE CASE WITH NORMAL STANDARDS AND RESULTS."

  Patient problems: No Code Available

  MAUDE report 7456571 ↗
• MalfunctionMay 20, 2016Charred; Charred

  ACCORDING TO THE REPORT, "HP [HANDPIECE] WAS FIRED AND IT WOULD NOT WORK. SO STAFF OPENED ANOTHER HP AND COMPLETED THE CASE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5669580 ↗
• MalfunctionSep 22, 2015Calibration Error

  ACCORDING TO THE REPORT, "CIRCULATOR WAS GETTING THE HAND PIECE READY FOR USE YET IT WAS NOT WORKING PROPERLY." THE HOSPITAL PROVIDED INFORMATION WHICH STATED "THE LASER WOULD NOT PASS THE CALIBRATION PROCESS ON FOUR DIFFERENT TRIES." THE PROCEDURE WAS DELAYED 20 MINUTES AS ANOTHER HANDPIECE WAS OBTAINED AND USED WITHOUT ANY FURTHER ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5093522 ↗