Facility

SHOCKWAVE MEDICAL, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3015053858
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	5403 Betsy Ross Drive Santa Clara, CA, US 95054
Registration status	Active · expires 2026
Parent company	Shockwave Medical, Inc. (owner-operator 10046972)
Brand names	Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Percutaneous Catheter, Ultrasound
Product code PPN (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250

Recalls & enforcement

Class IITerminated2018-07-18
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).

FDA inspections (2)

NAI2019-10-09
No Action Indicated · Compliance: Devices
NAI2019-06-07
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SHOCKWAVE MEDICAL, INC. (FEI 3015053858) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015053858-shockwave-medical-inc/

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