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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device (SHERPA NX active guiding catheter) where the hazard is potential exposure to underlying stainless-steel braid wires due to material loss. Per the severity rubric, 'risk-of-harm products where injury has not yet been reported' corresponds to a High severity rating (score 3). No deaths, hospitalizations, or significant injuries are reported in the source text.
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
- 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.
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