Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 23 units of Sherpa NX Active Guiding Catheters because of 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 metadata explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Medtronic Vascular is recalling 23 units of the Sherpa NX Active Guiding Catheter, 6F CHAMP1.5, .070" (Reference SA6CHAMP15). The recall is due to a potential for extensive loss of primary segment material, which could expose underlying stainless-steel braid wires on a subset of these 6F Sherpa catheters.
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 recall includes all lot and serial numbers for the GTIN 00613994823397.
Healthcare providers and facilities should stop using the affected catheters and contact Medtronic Vascular for instructions on returning the devices. The U.S. Food and Drug Administration has classified this recall as Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 23
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: 00613994823397 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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Same hazard · material loss
See all →- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
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- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
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