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U.S. Department of Health and Human Services

Class 2 Device Recall AMS 700 Inflatable Penile Prosthesis

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  Class 2 Device Recall AMS 700 Inflatable Penile Prosthesis see related information
Date Initiated by Firm September 24, 2020
Date Posted November 06, 2020
Recall Status1 Open3, Classified
Recall Number Z-0427-2021
Recall Event ID 86562
Product Classification Prosthesis, penis, inflatable - Product Code JCW
Product AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
Code Information 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
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
508-683-4000
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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