Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss
Medtronic Vascular is recalling 3 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical).
Plain-English summary
Medtronic Vascular is recalling 3 units of the Sherpa NX Active Guiding Catheter, 6F MAC4.0 SH, .070" (REF SA6MAC40SH), for cardiovascular use. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2729-2019.
The recall is due to a potential for extensive loss of primary segment material on a subset of the 6F Sherpa catheters. This defect could expose the underlying stainless-steel braid wires. The agency has classified this recall as Class I.
The affected products were distributed worldwide to the United States, 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 the United Kingdom. The GTIN for the affected units is 00613994822017, and the recall covers all lot and serial numbers for this specific reference.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 00613994822017 All Lot/Serial Numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 191 recalled by Medtronic Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 191 products in this recall →Related recalls
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See all →- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
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- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
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