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Official recall record

AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump

Health Canada — Medical Devices · 2025-09-25 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2025-09-25
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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