The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2659-2019·Announced 2019-10-09

SHERPA NX Active Guiding Catheter recall due to potential exposure of stainless steel braid wires

A subset of SHERPA NX active guiding catheters may expose patients to underlying stainless steel braid wires due to material loss.

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

The U.S. Food and Drug Administration is recalling a batch of SHERPA NX active guiding catheters because there is a potential for extensive loss of primary segment material that could expose underlying stainless-steel braid wires. This recall affects a subset of 6F Sherpa catheters manufactured by Medtronic Vascular. No injuries or illnesses have been reported to date. Consumers who have received these catheters should discontinue use immediately and contact their healthcare provider or Medtronic Vascular for guidance. The worldwide distribution includes multiple countries such as the United States, Austria, Belgium, and others.

The recall is classified as a risk-of-harm product where no injuries have been reported yet. According to the severity rubric, this falls under High severity (score 3) because it involves a risk-of-harm medical device with no documented illness or injury. The hazard type is stainless-steel exposure from compromised catheter integrity.

The recalled product

Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5, .070", REF SA6AL15. for cardiovascular use
Manufacturer
Medtronic Vascular
Category
Medical Device — Guiding Catheter
Hazard
Affected units
208

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: 00613994842381 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 →

Related recalls

Same manufacturer · Medtronic Vascular

See all →

Similar recalls