medical Class II Updated 2020-11-18

Boston Scientific Corporation recalls AMS 700 MS Pump with and without InhibiZone, sold as individ

Recalled Product

AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UPNs 72404310 72404280 72404281 72404282 72404282-10 72404283 72404283-12 72404284 72404284-14 72404285 72404286 72404287 72404288 72404289 72404300 72404301 72404302 72404302-10 72404303 72404303-12 72404305 72404306 72404307 72404308 72404209 72404260 72404261 72404262 72404263 72404264 72404265 72404266 72404267 72404268 72404269 72404230 72404231 72404232 72404232-10 72404233 72404233-12 72404234 72404234-14 72404235 72404236 72404237 72404238 72404239 72404250 72404251 72404252 72404252-10 72404253 72404253-12 72404255 72404256 72404257 72404258 To determine if a UPN/serial number is impacted, visit: www.bostonscientific.com/lookup
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