American Medical Systems her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe.
Brand
American Medical Systems
Lot Codes / Batch Numbers
Lots 431803 & 436666
Products Sold
Lots 431803 & 436666
American Medical Systems is recalling her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American due to Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.
Recommended Action
Per FDA guidance
An Urgent Device Recall / Product Safety Advisory letter, dated January 25, 2006, was sent to all customers who have purchased Disposable Probes since 01/01/2005 or who have in their possession a Her Option console (whether customer owned or AMS owned). The letter informs customers of the issue and of the 2 lots being recalled. The letter also includes Safety Advisory Instruction which are to be posted on or near the Her Option Console. A Recall Acknowledgement Form is asked to be returned to American Medical Systems which serves as an indication that the customer read the notice, is returning affected product and have understood and posted the Safety Advisory instructions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026