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Terminated

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.

FDA Recall Z-0675-06 · Posted 2006-03-23

Recalling FirmAmerican Medical Systems
Recall StatusTerminated
Product CodeMNB
Date Initiated2006-01-13
Date Terminated2008-02-24
Product Quantity152

Reason for Recall

Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide. AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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