Z-0757-2013Class II

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

Name: Z-0757-2013 Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45...
Creator: Abbott Vascular
Published: 2011-11-30
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2011-11-30 / Terminated / root cause: manufacturing process

FDA source

Abbott Vascular began a recall of Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55... on 2011-11-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0757-2013
Classification: Class II
Status: Terminated
Initiated: 2011-11-30
Posted: 2013-01-31
Terminated: 2013-01-31
Recalling firm: Abbott Vascular
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.
Product code: NTE Temporary Carotid Catheter For Embolic Capture
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Lot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0757-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0757-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-31

Product code NTE

K081549Class IIRx Accunet Lp Embolic Protection SystemAbbott Laboratories / cleared 2008-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)