The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced… — Class II medical device recall Z-3247-2018
Terminated recall by Shockwave Medical, Inc., reported 2018-10-03, distributed in CO, TN, TX. Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6
| Recall number | Z-3247-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shockwave Medical, Inc., Fremont, CA, United States |
| Recall initiated | 2018-07-18 |
| Classified | 2018-09-25 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2020-01-22 |
| Distributed | CO, TN, TX |
| Countries outside the US | AT, DE, NZ |
| Quantity | 612 |
Product
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-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R, Manufacturer: Shockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539
Reason for recall
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.