SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
Reported: October 9, 2019 Initiated: March 15, 2019 #Z-2578-2019
Product Description
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
Reason for Recall
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Details
- Recalling Firm
- Medtronic Vascular
- Units Affected
- 17 units
- 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
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use. Recalled by Medtronic Vascular. Units affected: 17 units.
Why was this product recalled? ▼
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2019. Severity: Critical. Recall number: Z-2578-2019.
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