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Open, Classified

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

FDA Recall Z-0427-2021 · Posted 2020-11-06

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeJCW
Date Initiated2020-09-24
Product Quantity24,064

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.

Firm 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.

Root Cause

Process control

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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