Z-2701-2011

CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm

Name: Z-2701-2011 CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm
Creator: Codman & Shurtleff, Inc.
Published: 2011-03-21
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2011-03-21 / Terminated / root cause: labeling and UDI

FDA source

Codman & Shurtleff, Inc. began a recall of CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812 on 2011-03-21. The reason FDA records is "Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2701-2011
Status: Terminated
Initiated: 2011-03-21
Posted: 2011-06-29
Terminated: 2016-02-17
Recalling firm: Cerenovus, Inc.
Product: CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812
Product code: NJE Intracranial Neurovascular Stent
Reason for recall: Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Codman & Shurtleff, Inc.sent an "Urgent Medical Device Correction Notice" on March 21, 2011. The letter recommend the incorrect label be removed and discarded. There are 3 additional peel-off labels, 2 on the outer box and one on the pouch. All 3 of these contain the correct printed size information (28 mm) that can be used for applying to the inventory sheet, patient record or patient card, as needed. It is NOT required to return any of this product to Codman. Customer Service at 1-800-225-0460 or contact your local Codman Neurovascular Representative
Quantity in commerce: 380 units
Distribution: Worldwide - Nationwide (USA), Canada, Korea.
Product codes and lots: Lot Numbers: 01420432, 01420851, 01421192, 01421315, 01421338, 01421601, 01421949, 01422123, 01422396, 01422401, 02420432, VV1419796

Product code NJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)