Edwards is asking customers to return some of the delivery systems used with its Sapien M3 devices after receiving three reports of balloons bursting when inflated during the procedure.

Four lots of the Commander M delivery systems are covered in the recall, the FDA said. Units with other lot numbers are not affected and can continue to be used.

The four lots represent less than 200 delivery systems, an Edwards spokesperson told MedTech Dive in an emailed statement. The company is working with customers to complete the product return and replacement process.

Leerink Partners analysts, in a note to clients, said the problem appeared to be batch-specific, rather than a broader platform issue, and predicted little financial impact to Edwards.

The company recently began to roll out Sapien M3 in the U.S. and Europe after receiving regulatory approval last year. The treatment is intended for patients who are too frail for a mitral valve repair procedure or open heart surgery. CEO Bernard Zovighian, on an earnings call in July, characterized initial feedback from physicians as “very good.”

Edwards’ transcatheter mitral and tricuspid therapies business, which includes Sapien M3, is a fast-growing though still relatively small segment for the company. Zovighian said sales of Sapien M3, along with the Pascal and Evoque platforms, exceeded expectations in the latest quarter. Edwards raised its sales forecast for the TMTT portfolio and said the business was on track to reach $2 billion in sales in 2030.

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