Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used fo

FDA device recall Z-1276-2015 · posted 2015-03-17 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

Reason for recall

Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.

Action taken

The firm, Medtronic, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2015 to its consignees/customers. Medtronic representatives, beginning Monday, Feb 23, 2015 hand delivered the letter to US consignees/customers.. The letter was addressed to Physician, Risk Manager and Health Care Professional. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately quarantine all unused product; return all affected product to Medtronic; contact Customer Service at 1-800-848-9300 to initiate product return and to complete and return the Customer Confirmation Certificate to via email to: RS.CFQFCA@Medtronic.com or fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. In additions, consignees/customers should share this notification with others in your organization. Your Medtronic field representative may assist the customers with identifying suitable replacement product. If you have any questions, contact Customer Service at 1-800-848-9300.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DYB

Quantity affected

151 (4 US, 147 OUS)

Distribution

Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.

Date initiated

2015-02-23

Date posted

2015-03-17

Date terminated

2015-10-07

Location

Saint Paul, MN

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