Device product
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.
Z-1276-2015
Product summary
- Event
- Event 70644
- Status
- Terminated
- Classification
- Class I
- Quantity
- 151 (4 US, 147 OUS)
- Official record key
device-enforcement:Z-1276-2015
Official wording
Reason: Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
Code information: Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.
Distribution pattern: Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.
Derived failure modes
-
Unknown
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.