Recall Z-3247-2018 ยท PPN Percutaneous Catheter, Ultrasound
Shockwave Medical, Inc.
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
| Date | Jul 18, 2018 |
| Status | Terminated |
| Reason | Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM). |
| Root cause | Process control |
| Action | On 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 i |
| Quantity | 612 |
| Distribution | Domestic: CO, TN and TX Foreign: Austria, Germany and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System Shockwave Medical, Inc., Jun 27, 2018 |