Shockwave S4 IVL Catheters Recalled for Inflation Pressure Failure
Shockwave Medical is recalling 612 Shockwave S4 IVL Catheters because they may fail to maintain required inflation pressure during treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that poses a risk of harm during treatment, but the source text does not report any specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Shockwave Medical, Inc. is recalling 612 units of the Shockwave S4 IVL Catheters. These devices 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.
The recall is being conducted because the catheters are unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM). The affected units were distributed domestically in Colorado, Tennessee, and Texas, and internationally in Austria, Germany, and New Zealand.
Healthcare providers and patients should stop using the affected devices and contact Shockwave Medical for further instructions.
The recalled product
- 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…
- Manufacturer
- Shockwave Medical, Inc.
- Affected units
- 612
Distribution
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