Fremont, CA, United States
Shockwave Medical, Inc. recalls
1 recall recorded since 2018, most recently on 18 July 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 July 2018
- Terminated
- 22 January 2020
- Reason
- Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
- Distribution
- Domestic: CO, TN and TX Foreign: Austria, Germany and New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3247-2018
- 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, ilio-femoral, popliteal, infra
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.