Z-1276-2015 Class I Terminated
FDA device recall Z-1276-2015 was initiated by Medtronic Inc. Cardiac Rhythm Disease Management on February 23, 2015 and is designated Class I. 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. The recall status is terminated (terminated October 7, 2015). Affected quantity: 151 (4 US, 147 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2015
- Initiation Date
- February 23, 2015
- Termination Date
- October 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 151 (4 US, 147 OUS)
Product Description
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.
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 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.
Code Information
Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.