AMS Artificial Urinary Sphincter Control Pump: Mislabeled Packaging Recall
Boston Scientific recalled 16 units of AMS Artificial Urinary Sphincter Control Pumps due to mislabeled packaging where devices labeled as Pressure Regulating Balloons actually contained Control Pumps.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving mislabeled packaging of a surgical implant component. While the hazard is significant—patients could receive the wrong device component—no illnesses, injuries, or hospitalizations have been reported. Per the rubric, recalls with risk-of-harm where injury has not yet been reported score 3.
Plain-English summary
Boston Scientific Corporation is recalling 16 units of the AMS Artificial Urinary Sphincter Control Pump (UPN 72400098, Lot 32487464) distributed worldwide. The devices have an expiration date of September 24, 2028.
The recall is due to mislabeled packaging in which devices labeled as a Pressure Regulating Balloon (UPN 72400024) actually contained Control Pump units instead. This mislabeling could result in the wrong device component being implanted if the packaging is not carefully verified before use.
The affected units were distributed in the United States (Arizona, California, Colorado, Florida, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, New York, Oregon, Pennsylvania, Texas, Virginia, Washington) and internationally in Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.
Patients who may have received one of the affected units should contact their healthcare provider or Boston Scientific immediately. Healthcare providers should verify the contents of any received packages against the labeling and quarantine any units with discrepancies.
The recalled product
- Product
- AMS Artificial Urinary Sphincter Control Pump
- Manufacturer
- Boston Scientific Corporation
- Hazard
- mis-labeling
- wrong-component
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 1100366316
- 1100366309
- 1100366317
- 1100366310
- 1100366319
- 1100366311
- 1100366320
- 1100366312
- 1100366321
- 1100366313
- 1100366323
- 1100366314
- 1100366324
- 1100366315
- 1100366325. Expiration Date: 09/24/2028
Distribution
Distributed nationwide across the United States.
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