AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
Reported: November 18, 2020 Initiated: September 24, 2020 #Z-0427-2021
Product Description
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
Reason for Recall
The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 24,064
- Distribution
- Domestic distribution nationwide. Foreign distribution to Argentina Ecuador Lebanon Saudi Arabia Australia Estonia Malaysia Serbia Austria Finland Malta Singapore Bahrain France Mexico Slovenia Belarus Germany Netherlands South Africa Belgium Great Britain New Zealand South Korea Brazil Greece Norway Spain Canada Guatemala Panama Sweden Chile Hong Kong Poland Switzerland China India Portugal Taiwan Colombia Iran Puerto Rico Thailand Costa Rica Ireland Qatar Turkey Croatia Israel Romania United Arab Emirates Czech Republic Italy Russian Fed. Dominican Republic
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis. Recalled by Boston Scientific Corporation. Units affected: 24,064.
Why was this product recalled? ▼
The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2020. Severity: Moderate. Recall number: Z-0427-2021.
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