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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80865

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 18, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Shockwave Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-3247-2018
Recall number
Z-3247-2018
Initiated
July 18, 2018
Classification
Class II
Status
Terminated
Recalling firm
Shockwave Medical, Inc.
Quantity
612

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).

Code information

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

Distribution pattern

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

Field note

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