Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
This recall has been terminated (originally issued March 17, 2015).
- Recall Initiated
- February 23, 2015
- Posted
- March 17, 2015
- Terminated
- October 7, 2015
- Recall Number
- Z-1276-2015
- Quantity
- 151 (4 US, 147 OUS)
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.
Root Cause
Nonconforming Material/Component
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.