Medtronic Inc. Cardiac Rhythm Disease Management recalls Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used f…

Recall date

February 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1276-2015

FDA classification

Class I

Brand / firm

Medtronic Inc. Cardiac Rhythm Disease Management

Sold / distributed

Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.

Why it was recalled

Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.