AMS AdVance Male Sling System Recalled for Suture Degradation
American Medical Systems is voluntarily recalling the AdVance Male Sling System because the resorbable suture may degrade before the 15-month shelf life expires.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a medical device where the hazard is suture degradation prior to shelf life expiration, without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
American Medical Systems (AMS) is issuing a voluntary recall for specific lots of the AdVance Male Sling System. The device is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence. The recall affects 4,872 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall was initiated after AMS received a small number of complaints indicating that the resorbable suture in the sling did not last for the entire 15-month shelf life of the product. An internal investigation confirmed that some sutures degraded prior to the end of the shelf life. The affected part numbers and lot/serial ranges are 720088-01 (722022001 to 796127002), 720088-02 (722024001 to 790266012), and 72404224 (742528001 to 795689010).
Healthcare providers and patients should check their inventory and patient records to identify any affected units. Those with questions regarding the recall or the device should contact American Medical Systems, Inc.
The recalled product
- Product
- 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
- Manufacturer
- American Medical Systems, Inc.
- Hazard
- Affected units
- 4,872
Distribution
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