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Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart… recallZ-1225-2009 · Medtronic Inc · initiated Jan 26, 2009

Terminated All recalls posted in May 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Storage

What the company is doing

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.

Recall details

Recall number
Z-1225-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 26, 2009
Posted by the FDA
May 29, 2009
Recalling firm
Medtronic Inc
Quantity
5
Product code
DYE
FDA submissions
P990064
Distribution
Nationwide Distribution -- Including states of CT, FL, MD, MA, MI, NC, OH, OR, PA, SD, TN, TX, WI, and WA.

Product description

Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; 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.

Code information (models, lots, serial numbers)

Lot Serial Number  21A06D2415, 27A05F7021, 23A06W1410, 25A04V1591, and  29A07F0075.

Other devices under the same FDA submission

101 devices cleared under P990064 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 51220).

Sources and updates

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