Class Il Kensey Nash Corp

Company: Kensey Nash Corp.,
Date of Enforcement Report:8/9/2006

TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach, Recall # Z-1305-06

Alarm activation-A priming issue involving the flow control unit due to a software problem has caused false positive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting.

Lot number 48275, exp. 1/07

Kensey Nash Corp., Exton, PA, by letter on April 17, 2006. Firm initiated recall is complete.

69 kits

Germany and Italy

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.