The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2610-2019·Announced 2019-10-09

Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

Medtronic Vascular is recalling 246 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 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 246 units of the Sherpa NX Active Guiding Catheter, 6F 100CM 3DRC, reference number SA63DRCSH. The recall affects all lot and serial numbers for the product, which is intended for cardiovascular use.

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 could expose the underlying stainless-steel braid wires. The product was distributed worldwide to the United States and 24 other countries, including Austria, Belgium, France, Germany, and the United Kingdom.

Healthcare providers and facilities that have received these devices should stop using them and contact Medtronic Vascular for instructions on return or replacement. Consumers should not use the recalled catheters and should consult their healthcare provider if they have questions regarding the recall.

The recalled product

Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for cardiovascular use
Manufacturer
Medtronic Vascular
Category
Medical Device — Cardiovascular Catheter
Hazard
Affected units
246

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: 00613994823816 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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