Recall Z-1276-2015— Medtronic Inc. Cardiac Rhythm Disease Management
Class I · Terminated
Class I FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2015-02-23, terminated 2015-10-07. It names one FDA 510(k) clearance: K142684. 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.. Reason: Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies..
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-02-23
- Terminated
- 2015-10-07
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.