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

FDA device recall Z-0427-2021 · posted 2020-11-06 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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

Status

Open, Classified

Product code

JCW

Quantity 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 Belaru

Date initiated

2020-09-24

Date posted

2020-11-06

Location

Marlborough, MA