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Cath. Guide 7f 3drcc Launcher recallZ-0969-06 · Medtronic, Inc. · initiated Apr 5, 2006

Terminated All recalls posted in June 2006

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

Potential for non-sterility due to loss of package integrity

FDA root cause category: Other

What the company is doing

Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.

Recall details

Recall number
Z-0969-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 5, 2006
Posted by the FDA
Jun 1, 2006
Recalling firm
Medtronic, Inc.
Quantity
416 units
Product code
DQY
FDA submissions
K022764
Distribution
Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.

Product description

CATH. GUIDE 7F 3DRCC LAUNCHER CATHETER LA73DRC LA 7F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA73DRC

Code information (models, lots, serial numbers)

Lot Numbers: 0000006813 0000009012 0000009040 0000015848 0000031930 0000043653 0000043655 0000055236 0000055686 0000060347 0000068443 0000068446 0000074855 0000074857 0000079601 0000081441 0000083822 0000091563 0000097895 0000101072 0000101074 0000105403 0000115013 0000117385 0000123711 0000133675 0000138054 0000144973 0000149842 0000153958 0000160711 0000170645 0000174447 0000175189 0000187845 181734 184271 185910 187134 188547 201685 203306 205597 207631 208906 211159 214999 216576 218842 219217 221352

Other devices under the same FDA submission

9 devices cleared under K022764 — 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 35236).

Sources and updates

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