SEISMIQ™ FG-006919Recalls & reported problems
Bolt Medical, Inc. · Intravascular Lithotripsy Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850056723077), received between Sep 16, 2026 and Sep 16, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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.
Reports received per month
Most reported problems
Device problems
- 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.
InjurySep 16, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796945 ↗
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- 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 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
- SEISMIQ™ FG-006917Bolt Medical, Inc. · Percutaneous Catheter, Ultrasound2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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