Z-0778-2017Class II

ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for...

Name: Z-0778-2017 ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for...
Creator: Angiodynamics, Inc.
Published: 2016-09-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-09-28 / Terminated / root cause: design

FDA source

Angiodynamics, Inc. began a recall of ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or... on 2016-09-28. FDA classified it as Class II and gives the reason as "Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach...". 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-0778-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-28
Posted: 2016-12-16
Terminated: 2018-06-18
Recalling firm: Boston Scientific Corporation
Product: ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Product code: DYB Introducer, Catheter
Reason for recall: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
Root cause tag: design
FDA root cause: Component design/selection
Action: Angiiodynamics sent an Urgent Voluntary Medical Device Recall letter dated September 28, 2016, to all affected customers. Recall notifications were delivered by Federal Express. Customers were instructed to segregate and return all affected devices to AngioDynamics and to complete and return the Reply Verification Tracking Form, provided in the recall notification by fax to 1-800-782-1357. Customers were encouraged to forward a copy of the recall notification to all sites to which have distributed affected product. If affected product is located in your institution, please 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. 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 via to [email protected]. Customers with questions should contact customer service at 1-800-772-6446.
Quantity in commerce: 4 boxes
Distribution: Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX
Product codes and lots: Batch/Lot: 1) 5034283

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0778-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0772-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16
Z-0773-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16
Z-0774-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16
Z-0775-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16
Z-0776-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16
Z-0777-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16
Z-0778-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16

Product code DYB

K051655Class IIAngiodynamics, Inc., Micro Access KitsAngioDynamics, Inc. / cleared 2005-09-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)