Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 787

FDA device recall Z-0995-2014 · posted 2014-02-20 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

DWF

Quantity affected

19483 total (7669 US, 11814 OUS)

Distribution

Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgi

Date initiated

2014-01-30

Date posted

2014-02-20

Date terminated

2014-10-06

Location

Saint Paul, MN

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