Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A micr

FDA device recall Z-1537-2010 · posted 2010-05-04 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Managment

Reason for recall

The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.

Action taken

Medtronic issued an "Urgent Medical Device Notification" letter dated March 8, 2010 addressed to "Dear Valued Customer" and was sent to three locations at each customer site: Risk Management, Cardiovascular Surgery and Clinical Laboratory-Point of Care. The letter described the product and the issue, provided instructions for control and patient testing. The customer was requested to return an enclosed certificate as proof of notification. For further information, contact your Medtronic Sales Representative or call 1-763-391-9915.

Root cause

Process change control

Status

Terminated

Product code

JPA

Quantity affected

508 US, 36 OUS

Distribution

Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and Canada.

Date initiated

2010-03-08

Date posted

2010-05-04

Date terminated

2011-12-31

Location

Saint Paul, MN