The Recall Desk

Manufacturer

Shockwave Medical, Inc.

1 recall in our database name Shockwave Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2018-10-03

Of the 1 recalls from Shockwave Medical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-3247-2018·2018-10-03

    Shockwave S4 IVL Catheters Recalled for Inflation Pressure Failure

    Shockwave Medical is recalling 612 Shockwave S4 IVL Catheters because they may fail to maintain required inflation pressure during treatment.

    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…
    Category
    Medical Device
    Distribution
    3 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

ShockWave Medical (United States)

company in Santa Clara, United States

Country
United States
Founded
2009

Official website

Source: Wikidata (Q106411771), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.