Agency classClass IOur severity:Severe FDA (Devices)·Z-2562-2019·Announced 2019-10-09

Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

Medtronic Vascular is recalling 1,226 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 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 recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe).

Plain-English summary

Medtronic Vascular is recalling 1,226 units of the Sherpa NX Active Guiding Catheter, 6F, IMA 55CM .070" (Reference SA6IMAK), for cardiovascular use. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2562-2019.

The recall is issued because there is a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters. This defect could expose the underlying stainless-steel braid wires. The affected units are identified by GTIN 00613994824059 and include all lot and serial numbers.

The affected products 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 and patients should stop using the affected catheters and contact Medtronic Vascular for further instructions.

The recalled product

Product: SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
Manufacturer: Medtronic Vascular
Category: Medical Device — Cardiovascular Catheter
Hazard: structural-defect
material-loss
Affected units: 1,226

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 00613994824059 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 →

Same manufacturer · Medtronic Vascular

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Same hazard · structural defect