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Medtronic EOPA Arterial Cannula, Model # 77620. Lot:… recallZ-2420-2015 · Medtronic Perfusion Systems · initiated Jul 24, 2015

Class II Terminated All recalls posted in August 2015

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 Perfusion Systems 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

EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.

FDA root cause category: Packaging process control

What the company is doing

On July 24, 2015 Medtronic sales representatives began verbally notifying the customers of the issue, requesting quarantine and return of un-used, affected product Consignees were sent a Medtronic "Urgent Medical device Recall" letter dated August 2015. The letter was addressed to Risk Manger and Health Care Professional. The letter described the problem and the product involved in the recall. Advised consignees to quarantine and remove the product from their inventory and return it to Medtronic. Requested consignees to complete and return the Customer Confirmation Certificate via email to RS.CFQFCA@Medtronic com or fax to Medtronic 651-367-0612 to the attention of Customer Focused Quality. For questions contact your Medtronic Sales Representative or Lifeline Technical Services at 1-877-526-7890.

Recall details

Recall number
Z-2420-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 24, 2015
Posted by the FDA
Aug 19, 2015
Recalling firm
Medtronic Perfusion Systems
Quantity
221 (111 US, 110 OUS)
Product code
DWF
FDA submissions
K031037
Distribution
Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.

Product description

Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.

Code information (models, lots, serial numbers)

Lot number 2015060544;

Other devices under the same FDA submission

28 devices cleared under K031037 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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