SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF… — recall Z-2585-2019
U.S. FDA — Device Enforcement · United States · 2019-03-15 · Class I
As described by U.S. FDA — Device Enforcement: SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. for cardiovascular use
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Completed — the recalling firm has completed its actions
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom
Reported risk: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
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