Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C

FDA device recall Z-1225-2009 · posted 2009-05-29 · Terminated

Recall details

Recalling firm

Medtronic Inc

Reason for recall

Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.

Action taken

A Medtronic "Urgent Medical Device Recall Notice" dated January 26, 2009, was sent to Risk Managers of each affected account and to each Implanting Physician. The letter described the problem, product and informed consignees that they will be retrieving the non-implanted vales. If additional information is needed, customers are to contact their local Medtronic sales representative or technical services at 1-877-526-7890.

Root cause

Storage

Status

Terminated

Product code

DYE

Quantity affected

5

Distribution

Nationwide Distribution -- Including states of CT, FL, MD, MA, MI, NC, OH, OR, PA, SD, TN, TX, WI, and WA.

Date initiated

2009-01-26

Date posted

2009-05-29

Date terminated

2012-05-22

Location

Minneapolis, MN