SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling Sherpa NX Active Guiding Catheters, model 6F SR3.5 SH with .070" diameter, used in cardiovascular procedures. The catheters have a potential defect where the outer material layer may extensively wear away on some units, which could expose the underlying stainless-steel wire braid. This condition could potentially affect the catheter's performance during use.
Four units of this product were distributed worldwide, including to the United States and multiple countries in Europe and Asia. The recall affects all lot and serial numbers of this specific model (GTIN: 00613994822789). The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Reason for recall: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. Distribution: Worldwide distribution to 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 United Kingdom Quantity: 4 units Lot/code info: GTIN: 00613994822789 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.