Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 10116

FDA device recall Z-0757-2013 · posted 2013-01-31 · Terminated

Recall details

Recalling firm

Abbott Vascular

Reason for recall

The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.

Action taken

Abbott Vascular sent an "URGENT DEVICE RECALL" letter dated November 30, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to work with their local account representative to review their inventory, complete the attached Field Action Reconciliation/ Effectiveness Check Form and return any unused identified products to Abbott Vascular.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NTE

Quantity affected

1253 units (962 units in the US & Puerto Rico)

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.

Date initiated

2011-11-30

Date posted

2013-01-31

Date terminated

2013-01-31

Location

Temecula, CA

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