The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2574-2019·Announced 2019-10-09

Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Structural Defect

Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of 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 involves a structural defect in a medical device that could expose sharp stainless-steel wires, which meets the rubric criteria for a 'Severe' rating (structural defect or significant injury risk).

Plain-English summary

Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter, 6F, CHAMP0.5 SH, 100CM.070" (REF SA6CHAMP05SH), intended for cardiovascular use. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2574-2019.

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 the affected 6F Sherpa catheters. The source text does not report any specific injuries or illnesses associated with this defect.

The affected units 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 GTIN for the product is 00613994823427, and the recall applies to all lot and serial numbers for this specific reference.

The recalled product

Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for cardiovascular use
Manufacturer
Medtronic Vascular
Category
Medical Device — Cardiovascular Catheter
Hazard
Affected units
6

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: 00613994823427 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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