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U.S. Department of Health and Human Services

Class 2 Device Recall Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System

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 Class 2 Device Recall Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) Systemsee related information
Date Initiated by FirmJuly 18, 2018
Create DateSeptember 25, 2018
Recall Status1 Terminated 3 on January 22, 2020
Recall NumberZ-3247-2018
Recall Event ID 80865
510(K)NumberK180454 
Product Classification Percutaneous Catheter, Ultrasound - Product Code PPN
ProductThe 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
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
FEI Number 3015053858
Recalling Firm/
Manufacturer		 Shockwave Medical, Inc.
48501 Warm Springs Blvd Ste 108
Fremont CA 94539-7750
For Additional Information ContactNora Hadding
510-279-4262
Manufacturer Reason
for Recall		Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
FDA Determined
Cause 2		Process control
ActionOn 7/19/2018, the firm sent an Urgent Medical Device Recall Notice to distribution chain/consignees via e-mail informing them that, in some cases, the S4 Peripheral IVL Catheter is not performing as intended. We have seen instances of leaks in the balloon which prevent the balloon from staying inflated at 4 atm for the full course of lithotripsy application. There have been no reports of adverse clinical events related to this issue. This issue does not impact patients who were previously treated with the S4 device. Customers were instructed to discontinue use of all S4 IVL products listed in the recall and place it into quarantine until a Shockwave representative was able to arrange for the S4 IVL product to be returned to Shockwave Medical. The Shockwave representative retrieving the product from the customer is to complete the Acknowledgement and Receipt Form. Recall Contact Nora Hadding Vice President, Quality and Regulatory Affairs Email: nhadding@shockwavemedical.com Phone: 510-279-4262 Monday through Friday, 8:00 AM to 4:30 PM Pacific time.
Quantity in Commerce612
DistributionDomestic: CO, TN and TX Foreign: Austria, Germany and New Zealand
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = PPN
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