Sherpa NX Active Guiding Catheter recall
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use
Why was Sherpa NX Active Guiding Catheter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 00613994822222 All Lot/Serial Numbers
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use
- Recalling firm
- Medtronic Vascular
- Quantity
- 12 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
- Recall date
- October 9, 2019
- Classification
- Class I
- Status
- Completed
- Agency
- FDA (device)