Recalls / —

—#184038

Product

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

FDA product code

JCW — Prosthesis, Penis, Inflatable

Device class

Class 3

Medical specialty

Gastroenterology, Urology

Affected 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

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

On September 24, 2020, the firm issued Urgent Medical Device Removal letters to affected customers. Customers were instructed to do the following: 1. If you have affected inventory, immediately discontinue use of and segregate recalled product in a secure location for return to BSC. 2. Complete and return your response form via email or fax immediately. 3. Customers with affected inventory will receive an RGA# after emailing/faxing their form. Please wait to return any product until you receive the RGA#. 4. Return the recalled product to Boston Scientific Corporation.

Recalling firm

Firm

Boston Scientific Corporation

Address

300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291

Distribution

Distribution pattern

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

Timeline

Recall initiated

2020-09-24

Posted by FDA

2020-11-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #184038. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.