Recall MonitorHealth Products
AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare
Recall class: Type II
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.