—#79252

Product

Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID , T505C2301, T505C2301, T505C2501, T505C2101, T510C29ID, T510C25ID, and T510C27ID; Sterile LC; Rx only; Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN 55432-5604, Manufactured at: Santa Ana, Ca. Indicated for the replacement of malfunctioning native or aortic and mitral heart valves.

FDA product code: DYE — Replacement Heart-Valve
Device class: Class 3
Medical specialty: Cardiovascular
PMA numbers: P980043
Affected lot / code info: Lot Serial # 25A07L4976, 21A08D0985, 25A06H1684, 23A07T1262, 23A08B5266, 25A08F0564, 21A07R2878, 29M07V3883, 25M07T4827, and 27M07V0682.

Why it was recalled

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.

Root cause (FDA determination)

Storage

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc
Address: 710 Medtronic Pkwy, Minneapolis, Minnesota 55432-5603

Distribution

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

Timeline

Recall initiated: 2009-01-26
Posted by FDA: 2009-05-29
Terminated: 2012-05-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #79252. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.