FDA Devices recall · Reported November 14, 2012
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).
American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of compl…
American Medical Systems, Inc. recalled AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 … - a moderate-severity action.
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 … was recalled by American Medical Systems, Inc. in November 14, 2012. Reason: American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling …. Check the official notice for the remedy. Verify recall #Z-0259-2013 with the FDA Devices before acting.
The recall
American Medical Systems, Inc. issued this moderate-severity FDA Devices recall-American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling ….
- Moderate
- severity level
- 5K units
- affected scope
- Class II
- classification
- November 14, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0259-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).
Reason for recall
American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0259-2013 |
| Date reported | November 14, 2012 |
| Date initiated | October 19, 2012 |
| Recalling firm | American Medical Systems, Inc. |
| Firm location | Minnetonka, MN |
| Affected scope | 4872 |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Ne… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0259-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026