Z-0849-2013Class II

NEUROPATH 6Fx100 GUIDING CATH ST

Name: Z-0849-2013 NEUROPATH 6Fx100 GUIDING CATH ST
Creator: Codman & Shurtleff, Inc.
Published: 2013-01-11
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2013-01-11 / Terminated / root cause: design

FDA source

Codman & Shurtleff, Inc. began a recall of NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of... on 2013-01-11. FDA classified it as Class II and gives the reason as "Sterility of device may be compromised due to lack of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0849-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-02-20
Terminated: 2015-08-10
Recalling firm: Cerenovus, Inc.
Product: NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Product code: DQY Catheter, Percutaneous
Reason for recall: Sterility of device may be compromised due to lack of package integrity
Root cause tag: design
FDA root cause: Component design/selection
Action: Codman sent an Urgent Voluntary Product Recall Notification letter dated January 11, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check all inventory to determine if they have any affected product, use the included instructions to report inventory status, return and obtain replacement product. Customers were instructed to contact your local Codman Representative or Stericycle at 1-866-201-9077. For questions regarding this recall call 508-880-8100.
Quantity in commerce: 266 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.
Product codes and lots: All unexpired lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0849-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0842-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0843-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0844-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0845-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0846-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0847-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0848-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0849-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0850-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0851-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0852-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0853-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0854-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0855-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0856-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0857-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0858-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0859-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0860-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0861-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0862-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0863-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0864-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20
Z-0865-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20

Product code DQY

K052004Class IIVascon Neuropath Guiding CatheterVascon, LLC / cleared 2006-01-19

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)