Z-0588-2012

DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28...

Name: Z-0588-2012 DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28...
Creator: Angiodynamics, Inc.
Published: 2011-01-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-01-24 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics, Inc. began a recall of DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28 cm Str. Basic Kit, Catalog No./REF 10302804... on 2011-01-24. The reason FDA records is "AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use". 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-0588-2012
Status: Terminated
Initiated: 2011-01-24
Posted: 2012-01-11
Terminated: 2016-02-02
Recalling firm: Boston Scientific Corporation
Product: DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28 cm Str. Basic Kit, Catalog No./REF 10302804, STERILE --- AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 USA The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, AngioDynamics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 28, 2011 and response form via Certified Mail, Return Receipt Requested, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to identify and segregate the recalled lots; complete and return the enclosed DuraMax HemoDialysis Catheter Recall Reply Form via fax to: Attn: DuraMax HemoDialysis Catheter Recall Coordinator at 518-798-1360 (even if they don't have any product); and do not use the affected product, return and ship the recalled product to ANGIODYNAMICS (replacement product will be shipped upon receipt and confirmation of the returned product). If the customers are in immediate need for replacement product, they should fax the completed Recall Reply Form, along with a copy of the product label, to Customer Service at (518) 798-1360 or call us at (800) 772-6446, x1358 or x1363. 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 ANGIODYNAMICS customer service at 1-800-772-6446 or email to: [email protected].
Quantity in commerce: 503 units
Distribution: Nationwide distribution.
Product codes and lots: Lots 500139, 527573, 527755, C28714

Product code MSD

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)