Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling 4 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
Medtronic Vascular is recalling four units of the Sherpa NX Active Guiding Catheter, 6F, Noto SH, 100cm, 070" (Reference SA6NOTOSH). The device is intended for cardiovascular use and is identified by GTIN 00613994823014. The recall covers all lot and serial numbers for this specific configuration.
The recall is being issued because there is a potential for extensive loss of primary segment material on a subset of these catheters. This defect could expose the underlying stainless-steel braid wires. The affected units were distributed worldwide to the United States, Austria, Belgium, Bulgaria, the Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, the Netherlands, Poland, Portugal, the Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom.
The U.S. Food and Drug Administration has classified this as a Class I recall. Healthcare providers and patients should stop using the affected devices and contact Medtronic Vascular for further instructions or replacement.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 4
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: 00613994823014 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 →- SevereMedtronic Angiographic Guidewire Components Shipped Without Required Sterilization
FDA (Devices) · 2021-06-23
- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- HighMedtronic 6F Launcher Guide Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- SevereMedtronic Guide Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-03-17
Same hazard · material loss
See all →- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- SevereMedtronic Vascular Recalls Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09