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Patient Tracker 9733534xom Ent 1pk recallZ-1591-2014 · Medtronic Navigation, Inc. · initiated Apr 24, 2014

Class II Terminated All recalls posted in May 2014

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 Navigation, 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 Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709.

Recall details

Recall number
Z-1591-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 24, 2014
Posted by the FDA
May 9, 2014
Recalling firm
Medtronic Navigation, Inc.
Quantity
26,674 total
Product code
HAW
FDA submissions
K001284, K012937, K022074, K033621, K871247, K990214
Distribution
Nationwide Distribution

Product description

PATIENT TRACKER 9733534XOM ENT 1PK

Code information (models, lots, serial numbers)

Lot No.: 131212C 130827E 130827E 131113B 131203C 131113D 131018A 130212B 131105B 130429E 130815D 130815D 130815C 130409G 130409G 130510E 130422A 130410A 130510E 130409G

Other devices under the same FDA submission

27 devices cleared under K001284, K012937, K022074, K033621, K871247, K990214 — 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 68145).

Sources and updates

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