Z-0675-06

her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical...

Name: Z-0675-06 her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical...
Creator: American Medical Systems
Published: 2006-01-13
License: https://open.fda.gov/license/

American Medical Systems, Inc. / initiated 2006-01-13 / Terminated

FDA source

American Medical Systems began a recall of her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN... on 2006-01-13. The reason FDA records is "Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0675-06
Status: Terminated
Initiated: 2006-01-13
Posted: 2006-03-23
Terminated: 2008-02-24
Recalling firm: American Medical Systems, Inc.
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.
Product code: MNB Device, Thermal Ablation, Endometrial
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 root cause: 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
Product codes and lots: Lots 431803 & 436666

Product code MNB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)