SEISMIQ™ FG-006917Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850056723053), received between Jul 16, 2026 and Sep 22, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

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.

• MalfunctionSep 22, 2026Fluid/Blood Leak; Nonstandard Device

  Reportable based on device analysis completed on(b)(6)2026. It was reported that the balloon leaked. A 6.0X60 145CM SEISMIQ device was selected for use in an Intravascular Lithotripsy (IVL) procedure. During the procedure, a balloon leak was identified. The procedure was completed with the same device. There were no patient complications as a result of this event and the patient fully recovered.However, device analysis revealed a balloon tear/rupture along with a device fragment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857639 ↗
• MalfunctionJul 16, 2026Nonstandard Device; Connection Problem; Output Problem

  IT WAS REPORTED THAT THE CATHETER DID NOT DISPLAY INFLATION PRESSURE ON THE CONSOLE DESPITE THE BALLOON BEING INFLATED. A SEISMIQ IVL CATHETER WAS SELECTED FOR USE TO TREAT AN 80% STENOSED LESION WITH SEVERE CONCENTRIC CALCIFICATION AND MILD VESSEL TORTUOSITY IT WAS REPORTED THAT, AFTER THE BALLOON WAS DEFLATED USING THE INFLATOR AND SUBSEQUENTLY REINFLATED TO 4.0 ATMOSPHERES, THE PRESSURE DID NOT REGISTER ON THE CONSOLE SCREEN; HOWEVER, THE INFLATOR INDICATED 4.0 ATMOSPHERES, AND THE BALLOON WAS OBSERVED TO BE INFLATED. AN ALERT MESSAGE STATING "REMOVE AND REINSERT CATHETER CONNECTOR" WAS DISPLAYED ON THE CONSOLE. TROUBLESHOOTING WAS ATTEMPTED BY UNPLUGGING AND REINSERTING THE CATHETER AND BY DEFLATING AND REINFLATING THE BALLOON; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE DEVICE WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25847626 ↗