Recall Z-1276-2015 ยท DYB Introducer, Catheter
Medtronic Inc. Cardiac Rhythm Disease Management
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.
| Date | Mar 17, 2015 (initiated Feb 23, 2015) |
| Status | Terminated |
| Reason | Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies. |
| Root cause | Nonconforming Material/Component |
| Action | 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 comple |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142684 | FlexCath Select Steerable Sheath (10 French) Medtronic Cryocath, LP, Nov 6, 2014 |