Ams 700™ Inflatable Penile Prosthesis With Tenacio™ Pump
AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump Recall The AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump is being recalled across Canada due to a performance issue with the device. This recall affects the inflatable penile prosthesis units that were distributed throughout Canada. The FDA has classified this as a Class I recall, which is the most serious classification.
- Product
- AMS 700™ Inflatable Penile Prosthesis with TENACIO™ Pump
- Reason
- Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2025-09-25
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/9134bd97-ff30-4cda-9083-0095070ff700