Z-3259-2011

ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF...

Name: Z-3259-2011 ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF...
Creator: Angiodynamics Worldwide Headquarters
Published: 2011-06-07
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2011-06-07 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Worldwide Headquarters began a recall of ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE, MANUFACTURED IN USA, AngioDynamics... on 2011-06-07. The reason FDA records is "The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length". 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-3259-2011
Status: Terminated
Initiated: 2011-06-07
Posted: 2011-09-16
Terminated: 2012-10-18
Recalling firm: Angiodynamics Worldwide Headquarters
Product: ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE, MANUFACTURED IN USA, AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 Angiographic catheter
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm ANGIODYNAMICS, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2011 to the consignees via Certified Mail, Return Receipt Requested. The letter described the product, problem and action to be taken. The customers were instructed not to use the product and to return it to AngioDynamics, Inc. in Queensbury, NY. The letter also instructed the consignees to (1.) Identify and segregate the recalled lot that is in your possession, (2.) Complete the enclosed Soft-Vu Angiographic Catheter Recall Reply Form and fax it to the attention of the Soft-Vu Angiographic Catheter Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to ANGIODYNAMICS. (3.) Ship the recalled product to ANGIODYNAMICS. Replacement product will be shipped upon receipt and confirmation of the returned product. Reference Return Authorization Number XXXXXXXXXX on the outside of the shipping box and include a copy of the Soft-Vu Angiographic Catheter Recall Reply Form with your shipment. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call the Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. You may also e-mail your questions to [email protected].
Quantity in commerce: Domestic - 25 units; Foreign - 5 units
Distribution: Worldwide distribution: USA (nationwide) including states of: California, Tennessee, and Wisconsin, and country of: Spain.
Product codes and lots: Lot 517631, Use By 06/2013

Product code DQO

K061733Class IIAngiodynamics Soft-Vu and Mariner Hydrophilic Coated Angiographic CatheterAngioDynamics, Inc. / cleared 2006-08-24

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)