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Recall Observatory FDA recall evidence

Device product

SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use

Z-2564-2019

March 15, 2019

Class I

Product summary

Firm
Medtronic Vascular
Event
Event 82525
Status
Completed
Classification
Class I
Quantity
538 units
Official record key
device-enforcement:Z-2564-2019

Official wording

Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information: GTIN: 00613994823823 All Lot/Serial Numbers

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.