# FDA recall Z-3247-2018

> **Shockwave Medical, Inc.** · Class II · device recall initiated 2018-07-18.

## 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).

## Distribution

Domestic: CO, TN and TX  Foreign: Austria, Germany and New Zealand

## Key facts

- **Recall number:** Z-3247-2018
- **Recalling firm:** Shockwave Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-18
- **Report date:** 2018-10-03
- **Termination date:** 2020-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3247-2018

## Citation

> AI Analytics. FDA recall Z-3247-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3247-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*