The Recall Desk
SevereFDA (Devices)·Z-2750-2019·Announced 2019-10-09

Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

Medtronic Vascular is recalling 80 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

What this means for you

Illness, injury, or structural failure has been reported. 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 exposes underlying stainless-steel braid wires, which poses a significant risk of injury during cardiovascular procedures.

Plain-English summary

Medtronic Vascular is recalling 80 units of the Sherpa NX Active Guiding Catheter, 6F JL3.5, .070", reference SA6JL355. The product is intended for cardiovascular use and was distributed worldwide to the United States and 24 other countries, including Austria, Belgium, and the United Kingdom.

The recall is due to a potential for extensive loss of primary segment material on a subset of the 6F Sherpa catheters. This defect may expose the underlying stainless-steel braid wires. The recall applies to all lot and serial numbers for the specific GTIN 20613994822233.

Healthcare providers and facilities should stop using the affected catheters and contact Medtronic Vascular for further instructions. Consumers should not use these medical devices and should contact their healthcare provider if they have questions about the recall.

The recalled product

Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use
Manufacturer
Medtronic Vascular
Affected units
80

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: 20613994822233 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 →