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Medtronic Intersept Custom Tubing Pack which contain Select… recallZ-1000-2014 · Medtronic Inc. Cardiac Rhythm Disease Management · initiated Jan 30, 2014

Class II Terminated All recalls posted in February 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 Inc. Cardiac Rhythm Disease Management 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 is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm, Medtronic, sent an "Urgent Medical Device Recall" letter dated January, 2014 via UPS on January 30, 2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all listed product in your inventory; return all listed product to Medtronic and contact Customer Service at 800 854-3570 and reference RADAR #167826 to initiate a return and credit of product; complete and return the attached Customer Confirmation Certificate via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality, and share this notification with others in your organization as appropriate. Select 3D and Select CAP Arterial Cannula are not available for purchase at this time. Please contact your Medtronic sales representative or Medtronic LifeLine Technical Services at 1 877-526-7890 or (+1 763) 526-7890 to assist with alternative cannula selection and any additional questions you may have related to this notification.

Recall details

Recall number
Z-1000-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 30, 2014
Posted by the FDA
Feb 20, 2014
Recalling firm
Medtronic Inc. Cardiac Rhythm Disease Management
Quantity
19483 total (7669 US, 11814 OUS)
Product code
DWE
FDA submissions
K800178
Distribution
Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.

Product description

Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.

Code information (models, lots, serial numbers)

Model 3Y90R3, Lot numbers: 12227513, 12277464, 206420618, 206618641, 206842458, 206932996, 207184816.   Model C300901B, Lot number 206499164.

Other devices under the same FDA submission

113 devices cleared under K800178 — 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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