The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2637-2019·Announced 2019-10-09

Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

Medtronic Vascular is recalling specific Sherpa NX Active Guiding Catheters due to a potential loss of material that could expose underlying stainless-steel 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 recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters."

Plain-English summary

Medtronic Vascular is recalling the Sherpa NX Active Guiding Catheter, 6F SCR4.0 SH, .070" (REF SA6SCR40SH), which is used for cardiovascular procedures. The recall involves a subset of these 6F catheters where there is a potential for extensive loss of primary segment material. This defect could result in the exposure of underlying stainless-steel braid wires.

The affected devices were distributed worldwide to the United States and various international locations, including 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. The recall covers all lot and serial numbers for the specific GTIN 00613994822574.

Healthcare providers and facilities should stop using the affected catheters and contact Medtronic Vascular for further instructions on the recall process.

The recalled product

Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for cardiovascular use
Manufacturer
Medtronic Vascular
Category
Medical Device — Cardiovascular Catheter
Hazard

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: 00613994822574 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 →

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