Z-1765-2024Class II

DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for...

Name: Z-1765-2024 DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for...
Creator: Angiodynamics, Inc.
Published: 2024-03-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-03-18 / Open, Classified

FDA source

Angiodynamics, Inc. began a recall of DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195 on 2024-03-18. FDA classified it as Class II and gives the reason as "Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1765-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-18
Posted: 2024-05-03
Recalling firm: Boston Scientific Corporation
Product: DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
FDA root cause: Under Investigation by firm
Action: Angiodynamics issued Recall Notifications Packages via Federal Express to 1 Domestic Consignee on 2024-03-18 . Letter states reason for recall, health risk and action to take: IMMEDIATELY o Locate the affected product in your Inventory, cease any and all distribution segregate in a secure location pending return. o Forward a copy of this recall notification to any locations to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. " Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return), following the directions on this page and the Reply Verification Tracking Form. Email Reply Verification Tracking Form (preferred): [email protected] Fax Reply Verification Tracking Form: Attn: Hemodialysis Catheter Kits with Tri-Ball Tunneller Fax number 1-855-273-0519 " Call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Package any product that is being returned in an appropriate shipping box. " Write the RMA number on the RMA label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. " Seal the box and return via your preferred carrier to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: Hemodialysis Catheter Kits with Tri-Ball Tunneller
Quantity in commerce: 65 units
Distribution: VA
Product codes and lots: UDI-DI: 25051684014837 Lot Numbers: 5807415

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1765-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1760-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1761-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1762-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1763-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1764-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1765-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1766-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1767-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1768-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1769-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1770-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1771-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1772-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1773-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03
Z-1774-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03

Product code MSD

K110936Class IIDuraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. / cleared 2011-06-10

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)