Shockwave Medical recalls S4 IVL catheters due to potential inflation pressure failure during treatment. Affected units have specific sizes, lot numbers, and UDI codes. Consumers should contact the manufacturer for details.
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Shockwave Medical is recalling S4 IVL catheters used for treating vascular lesions. The catheters may fail to maintain proper inflation pressure during treatment, which could lead to complications. This recall affects specific sizes and production batches.
The catheters may not maintain the required inflation pressure (4ATM during treatment and 6ATM after) which could cause the catheter to deflate unexpectedly. This might lead to complications during vascular procedures if the catheter fails to stay inflated.
Patients undergoing vascular lesion treatment with Shockwave S4 IVL catheters are most at risk. Healthcare providers using these catheters for lithotripsy-enhanced procedures may also be affected.
Check for the product size (2.5mm, 3.0mm, 3.5mm, or 4.0mm), lot numbers starting with P180222A-P180503D, and UDI codes like M732S4IVL25400. The catheters are sold under the Shockwave S4 IVL brand.
Identify the size, lot number, and UDI code to confirm if your catheter is affected.
Reach out to Shockwave Medical at 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539 for specific guidance.
The recall indicates a potential risk of inflation pressure failure, so they should not be used until the manufacturer provides further instructions.
The catheters may not maintain the required inflation pressure (4ATM during treatment and 6ATM after) which could lead to unexpected deflation during procedures.
Check for the size (2.5mm, 3.0mm, 3.5mm, or 4.0mm), lot numbers starting with P180222A-P180503D, and UDI codes like M732S4IVL25400.
We’ve drafted a message you can send Shockwave to request your refund or repair — edit it as you like.
Subject: Recall Z-3247-2018 — Shockwave Shockwave Hello, I own a Shockwave that is covered by recall Z-3247-2018 from Shockwave. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
