Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Medtronic Recalled by Medtronic Inc. Cardiac Rhythm Disease Management Due to Clinicians observed debris, appearing to originate from the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc. Cardiac Rhythm Disease Management directly.
Affected Products
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.
Quantity: 151 (4 US, 147 OUS)
Why Was This Recalled?
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Inc. Cardiac Rhythm Disease Management has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report