FDA Device recall Z-3247-2018
The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the per…
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the per… by Shockwave Medical, citing catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3247-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-18 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Shockwave Medical |
| Distribution | CO, TN, TX |
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
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Identifiers
| code_info | Catalog No. Part No. Size Lot # UDI (DI Portion Only) S4IVL2540 FG61163-25…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3247-2018%22
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