Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 305 units of Sherpa NX Active Guiding Catheters because a defect may 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, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Medtronic Vascular is recalling 305 units of the Sherpa NX Active Guiding Catheter, 6F LCB, .070" (Reference SA6LCB). These devices are used for cardiovascular procedures. The recall covers all lot and serial numbers for the product, identified by GTIN 00613994821713.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of the 6F Sherpa catheters. This defect may expose the underlying stainless-steel braid wires. The agency has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The affected devices were distributed worldwide to the United States, Austria, Belgium, Bulgaria, the Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, the Netherlands, Poland, Portugal, the Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom. Healthcare providers should stop using the affected devices and contact Medtronic Vascular for instructions on return or replacement.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB, .070", REF SA6LCB. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 305
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: 00613994821713 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
- 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 Vascular Recalls Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09
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