Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 51 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a severity score of at least 4 per the rubric.
Plain-English summary
Medtronic Vascular is recalling 51 units of the Sherpa NX Active Guiding Catheter, 6F JR3.0 SH, .070" (REF SA6JR30SH). The recall affects all lot and serial numbers for the GTIN 00613994822406. The product is intended for cardiovascular use.
The recall was initiated because there is a potential for extensive loss of primary segment material, which could expose the underlying stainless-steel braid wires on a subset of the 6F Sherpa catheters. The agency has classified this recall as Class I.
The affected units 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 JR3.0 SH, .070", REF SA6JR30SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 51
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: 00613994822406 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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FDA (Devices) · 2019-10-09
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