Recall Z-3247-2018— Shockwave Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Shockwave Medical, Inc., initiated 2018-07-18, terminated 2020-01-22. It names one FDA 510(k) clearance: K180454. 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)..
- Recalling firm
- Shockwave Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-18
- Terminated
- 2020-01-22
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Data sourced from openFDA. This site is unofficial and independent of the FDA.