SEISMIQ™ FG-006915Recalls & reported problems
Bolt Medical, Inc. · Intravascular Lithotripsy Catheter · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850056723039), received between May 6, 2026 and May 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Difficult to Remove; Material Rupture
IT WAS REPORTED THAT THE BALLOON BURST AND BECAME DIFFICULT TO REMOVE. A SEISMIQ ATK CATHETER WAS SELECTED FOR USE IN A PAD (PERIPHERAL ARTERY DISEASE) PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST AND BECAME DIFFICULT TO REMOVE. THE WHOLE SYSTEM WAS TAKEN OUT WITH THE WIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25107654 ↗
Other Percutaneous Catheter, Ultrasound devices
- Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL7060Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound8 reports
- Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL080030Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound7 reports
- Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL120030Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound3 deaths7 reports
- Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter L6IVL100030Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound2 deaths6 reports
- SEISMIQ™ FG-010978Bolt Medical, Inc. · Percutaneous Catheter, Ultrasound3 reports
- Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL050080Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound2 reports
- Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL5060Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound2 reports
- Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter M5IVL6560Shockwave Medical, Inc. · Percutaneous Catheter, Ultrasound2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.