CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report
The Shockwave S4 IVL Catheters are intended recalled
Shockwave Medical is recalling The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation, distributed in Colorado, Tennessee, Texas. The recall was initiated on 18 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3247-2018
- FDA event ID
- 80865
- Recalling firm
- Shockwave Medical, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2018
- FDA classified
- 25 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 18 Jul 2018 | Recall initiated by company | |
| 25 Sep 2018 | Classified by FDA | +69 days |
| 3 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Domestic: CO, TN and TX Foreign: Austria, Germany and New Zealand
Questions about this recall
Is The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation recalled?
Yes. Shockwave Medical recalled The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation on 18 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-3247-2018.
Why was it recalled?
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Which lots are affected?
Catalog No. Part No. Size Lot # UDI (DI Portion Only) S4IVL2540 FG61163-2540 2.50x40mm P180222I M732S4IVL25400 P180327A P180410A P180503A S4IVL3040 FG61163-3040 3.00x40mm P180223A M732S4IVL30400 P180327B P180410B P180503B S4IVL3540 FG61163-3540 3.50x40mm P180223B M732S4IVL35400 P180327C P180410C P180503C S4IVL4040 FG61163-4040 4.00x40mm P180223C M732S4IVL40400 P180327D P180410D P180503D
Where was it sold?
Domestic: CO, TN and TX Foreign: Austria, Germany and New Zealand
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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