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SEISMIQ™
Bolt Medical, Inc. · Model FG-006921 · UDI-DI 00850056723091
PPN
Prescription
10
510(k) clearances
243
Adverse events (19 deaths)
1
Recalls
11
Facilities
Description
Intravascular Lithotripsy Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-18 | Shockwave Medical, Inc. | Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM). |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.