CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male recalled
American Medical Systems is recalling AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02, distributed nationwide in the US. The recall was initiated on 19 Oct 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0259-2013
- FDA event ID
- 63540
- Recalling firm
- American Medical Systems, Minnetonka, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Oct 2012
- FDA classified
- 7 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Oct 2012 | Recall initiated by company | |
| 7 Nov 2012 | Classified by FDA | +19 days |
| 14 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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).
Where it was distributed
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, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan.
Questions about this recall
Is AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 recalled?
Yes. American Medical Systems recalled AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 on 19 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0259-2013.
Why was it recalled?
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
Which lots are affected?
Part # Lot/Serial Range 720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010
Where was it sold?
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, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Medical Systems
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | AMS Monarc + Subfascial Hammock with Tensioning Suture recalled | American Medical Systems | Foreign Material | Nationwide |
| Device | CLASS II | AdVance"Male Sling System recalled by American Medical Systems | American Medical Systems | Foreign Material | Nationwide |
| Device | CLASS II | AMS 700 Series Inflatable Penile Prosthesis Accessory Kit recalled | American Medical Systems | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | AMS 800¿ Urinary Control System recalled by American Medical Systems | American Medical Systems | Other | Nationwide |
| Device | CLASS II | AMS 800¿ Urinary Control System recalled by American Medical Systems | American Medical Systems | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |