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U.S. Department of Health and Human Services

Class 2 Device Recall AMS Her Option Cryoablation Therapy Disposable Probe

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  Class 2 Device Recall AMS Her Option Cryoablation Therapy Disposable Probe see related information
Date Initiated by Firm January 13, 2006
Date Posted March 23, 2006
Recall Status1 Terminated 3 on February 24, 2008
Recall Number Z-0675-06
Recall Event ID 34426
PMA Number P000032 
Product Classification Device, Thermal Ablation, Endometrial - Product Code MNB
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.
Code Information Lots 431803 & 436666
Recalling Firm/
Manufacturer		 American Medical Systems
10700 Bren Rd W
Minnetonka MN 55343-9679
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 152
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MNB and Original Applicant = CooperSurgical, Inc.
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