Drug recall
The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including…
FDA recall event 80865 · Class II · Shockwave Medical, Inc.
Key facts
| Event ID | 80865 |
|---|---|
| Recall numbers | Z-3247-2018 |
| Recalling firm | Shockwave Medical, Inc. |
| Product type | Devices |
| Products | The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM). |
| Initiation date | Jul 18, 2018 |
| Report date | Oct 3, 2018 |
| Termination date | Jan 22, 2020 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 3010940016 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: