Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 159 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing 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 agency classification is Class I, and the rubric mandates a score of at least 4 for FDA Class I recalls.
Plain-English summary
Medtronic Vascular is recalling 159 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070", REF SA6RBU40. The product is intended for cardiovascular use. The recall affects all lot and serial numbers for the GTIN 00613994822963.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of these catheters. This defect may expose underlying stainless-steel braid wires.
The affected products were distributed worldwide to the US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the recalled units.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070", REF SA6RBU40. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 159
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: 00613994822963 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