Angiodynamics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0778-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: September 28, 2016

Date Posted: December 28, 2016

Recall Number: Z-0778-2017

Event ID: 75420

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.

Status: Terminated

Product Quantity: 4 boxes

Code Information:

Batch/Lot: 1) 5034283

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated