AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump
Brand(s)
Last updated
Summary
Product
AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| AMS 700 LGX™ TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404450 |
| AMS 700 LGX™ TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404452 |
| AMS 700 LGX™ TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404451 |
| AMS 700 LGX™ TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404453 |
| AMS 700 LGX™ TENACIO™ Pump, Preconnected - Infrapubic Inhibizone | More than 10 numbers, contact manufacturer. | 72404456 |
| AMS 700 LGX™ TENACIO™ Pump, Preconnected - Infrapubic Inhibizone | More than 10 numbers, contact manufacturer. | 72404455 |
| AMS 700 LGX™ TENACIO™ Pump, Preconnected - Infrapubic Inhibizone | More than 10 numbers, contact manufacturer. | 72404457 |
| AMS 700 LGX™ TENACIO™ Pump, Preconnected - Infrapubic Inhibizone | More than 10 numbers, contact manufacturer. | 72404458 |
| AMS 700 LGX™ TENACIO™ Pump Preconnected - Penoscrotal | More than 10 numbers, contact manufacturer. | 72404402 |
| AMS 700 LGX™ TENACIO™ Pump Preconnected - Penoscrotal | More than 10 numbers, contact manufacturer. | 72404403 |
| AMS 700 LGX™ TENACIO™ Pump Preconnected - Penoscrotal | More than 10 numbers, contact manufacturer. | 72404400 |
| AMS 700™ CXR TENACIO™ Pump, Preconnected - Infrapubic Inhibizone | More than 10 numbers, contact manufacturer. | 72404469 |
| AMS 700™ CXR TENACIO™ Pump, Preconnected - Infrapubic Inhibizone | More than 10 numbers, contact manufacturer. | 72404467 |
| AMS 700™ CXR TENACIO™ Pump, Preconnected - Infrapubic Inhibizone | More than 10 numbers, contact manufacturer. | 72404468 |
| AMS 700™ CXR TENACIO™ Pump, Preconnected - Infrapubic Inhibizone | More than 10 numbers, contact manufacturer. | 72404465 |
| AMS 700™ CXR TENACIO™ Pump, Preconnected - Infrapubic Inhibizone | More than 10 numbers, contact manufacturer. | 72404466 |
| AMS 700 LGX™ TENACIO™ Pump Preconnected - Infrapubic | More than 10 numbers, contact manufacturer. | 72404407 |
| AMS 700 LGX™ TENACIO™ Pump Preconnected - Infrapubic | More than 10 numbers, contact manufacturer. | 72404405 |
| AMS 700 LGX™ TENACIO™ Pump Preconnected - Infrapubic | More than 10 numbers, contact manufacturer. | 72404408 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Infrapublic Inhibizone | More than 10 numbers, contact manufacturer. | 72404438 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Infrapublic Inhibizone | More than 10 numbers, contact manufacturer. | 72404435 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Infrapublic Inhibizone | More than 10 numbers, contact manufacturer. | 72404439 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Infrapublic Inhibizone | More than 10 numbers, contact manufacturer. | 72404437 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Infrapublic Inhibizone | More than 10 numbers, contact manufacturer. | 72404436 |
| AMS 700™ TENACIO™ Pump Inhibizone | More than 10 numbers, contact manufacturer. | 72404469 |
| AMS 700™ CX TENACIO™ Pump Preconnected - Penoscrotal | More than 10 numbers, contact manufacturer. | 72404483 |
| AMS 700™ CX TENACIO™ Pump Preconnected - Penoscrotal | More than 10 numbers, contact manufacturer. | 72404482 |
| AMS 700™ CX TENACIO™ Pump Preconnected - Penoscrotal | More than 10 numbers, contact manufacturer. | 72404484 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404432 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404433 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404431 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404434 |
| AMS 700™ CX TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404430 |
| AMS 700™ CX TENACIO™ Pump Preconnected - Infrapubic | More than 10 numbers, contact manufacturer. | 72404487 |
| AMS 700™ CX TENACIO™ Pump Preconnected - Infrapubic | More than 10 numbers, contact manufacturer. | 72404488 |
| AMS 700™ CX TENACIO™ Pump Preconnected - Infrapubic | More than 10 numbers, contact manufacturer. | 72404486 |
| AMS 700™ CXR TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404461 |
| AMS 700™ CXR TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404463 |
| AMS 700™ CXR TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404462 |
| AMS 700™ CXR TENACIO™ Pump, Preconnected - Penoscrotal Inhibizone | More than 10 numbers, contact manufacturer. | 72404464 |
| AMS 700™ TENACIO™ Pump | More than 10 numbers, contact manufacturer. | 72404420 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78126
Get notified
Receive emails about new and updated recall and safety alerts.