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Health Canada Medical devices

AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump

Issued September 25, 2025
Issue
Boston Scientific is voluntarily initiating a product recall of specific serial numbers of the AMS 700™ Inflatable Penile Prosthesis (IPP) with TENACIO™ pump following identification of a manufacturing issue that may impact pump inflation and/or deflation.
Hazard description
Performance
Product
Product name
AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump
Reference
ID
RA-78126