Recall Z-0757-2013— Abbott Vascular

Name: FDA recall Z-0757-2013
Creator: U.S. Food and Drug Administration
Published: 2011-11-30

Class II · Terminated

Class II FDA medical device recall by Abbott Vascular, initiated 2011-11-30, terminated 2013-01-31. It names one FDA 510(k) clearance: K081549. Product: Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.. Reason: 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..

Recalling firm: Abbott Vascular
Classification: Class II
Status: Terminated
Initiated: 2011-11-30
Terminated: 2013-01-31
Firm location: Temecula, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081549 — RX ACCUNET LP EMBOLIC PROTECTION SYSTEMAbbott Laboratories·cleared 2008-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.