Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling 8 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material that could expose underlying stainless-steel braid wires.
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 with a structural defect that could expose sharp stainless-steel wires, representing a risk of harm to patients, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Medtronic Vascular is recalling eight units of the Sherpa NX Active Guiding Catheter, 6F, MPH, 55CM, 070" (Reference SA6MPHK), for cardiovascular use. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2598-2019.
The recall is due to a potential for extensive loss of primary segment material on a subset of the 6F Sherpa catheters. This defect could expose the underlying stainless-steel braid wires. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The affected units were distributed worldwide to the United States, 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 GTIN for the product is 00613994823076, and the recall applies to all lot and serial numbers.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, MPH, 55CM, 070", REF SA6MPHK. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 8
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: 00613994823076 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 defect
See all →- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- HighLight Boy Recalls GBX12SK Light Towers Due to Frame Bending Risk
NHTSA · 2026-09-01
- SevereKmaier Infant Walkers Recalled for Serious Fall Hazard
CPSC · 2026-08-27
- Highrestor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
FDA (Devices) · 2026-08-26
- SevereFord Recalls 2026 Maverick, F-150, and Bronco Sport for Joint Issues
NHTSA · 2026-08-25