Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 49 units of the SHERPA NX Active Guiding Catheter because a subset may experience extensive loss of primary segment material, exposing underlying stainless-steel braid wires.
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 classification is FDA Class I, which according to the rubric mandates a minimum severity score of 4. Additionally, the defect involves structural failure (material loss exposing wires) in a medical device used for cardiovascular procedures, indicating a significant risk of serious injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has announced a Class I recall of the SHERPA NX Active Guiding Catheter, 6F JL3.0 SH, .070", REF SA6JL30SH, manufactured by Medtronic Vascular. This product is intended for cardiovascular use.
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 the underlying stainless-steel braid wires, which poses a risk to patients during use.
A total of 49 units are affected. The distribution pattern includes worldwide distribution to the United States and numerous other countries including 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 affected units are identified by GTIN 00613994822253 and all lot/serial numbers.
Healthcare providers and patients should stop using the recalled catheters immediately. Medtronic Vascular is responsible for this recall action.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 49
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: 00613994822253 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 · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- SevereCodman & Shurtleff Recalls Neuropath Guiding Catheters Due to Sterility Concerns
FDA (Devices) · 2013-02-27
- HighCodman Neuropath Guiding Catheters Recalled for Potential Sterility Compromise
FDA (Devices) · 2013-02-27
- HighCodman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2013-02-27
- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- HighMedtronic Archer Super Stiff Guidewire Recalled for Coating Separation Risk
FDA (Devices) · 2013-04-03
- ModerateMedtronic Launcher Guiding Catheter Recalled for Labeling Errors
FDA (Devices) · 2013-07-03