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Ams 700™ inflatable penile prosthesis with tenacio™ pump

Official notice

25 Sept 2025

MediumHealth Canada

An official Health Canada notice concerns Ams 700™ inflatable penile prosthesis with tenacio™ pump. 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. Published 2025-09-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

78126

Official notice

2025-09-25

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

78126

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Affected products

Product 1

Affected products - AMS 700 LGX™ TENACIO™ Pump Preconnected - Penoscrotal, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404402

Product 2

Affected products - AMS 700 LGX™ TENACIO™ Pump Preconnected - Penoscrotal, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404403

Product 3

Affected products - AMS 700 LGX™ TENACIO™ Pump Preconnected - Penoscrotal, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404400

Product 4

Affected products - AMS 700 LGX™ TENACIO™ Pump Preconnected - Infrapubic, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404407

Product 5

Affected products - AMS 700 LGX™ TENACIO™ Pump Preconnected - Infrapubic, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404405

Product 6

Affected products - AMS 700 LGX™ TENACIO™ Pump Preconnected - Infrapubic, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404408

Product 7

Affected products - AMS 700™ TENACIO™ Pump Inhibizone, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404469

Product 8

Affected products - AMS 700™ CX TENACIO™ Pump Preconnected - Penoscrotal, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404483

Product 9

Affected products - AMS 700™ CX TENACIO™ Pump Preconnected - Penoscrotal, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404482

Product 10

Affected products - AMS 700™ CX TENACIO™ Pump Preconnected - Penoscrotal, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404484

Product 11

Affected products - AMS 700™ CX TENACIO™ Pump Preconnected - Infrapubic, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404487

Product 12

Affected products - AMS 700™ CX TENACIO™ Pump Preconnected - Infrapubic, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404488

Product 13

Affected products - AMS 700™ CX TENACIO™ Pump Preconnected - Infrapubic, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404486

Product 14

Affected products - AMS 700™ TENACIO™ Pump, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 72404420

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Boston Scientific, Ams 700™ Inflatable Penile Prosthesis With Tenacio™ Pump.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

78126

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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