SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75 SH, .070", REF SA6AL75SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 573 units of the Sherpa NX Active Guiding Catheter, 6F AL.75 SH, .070" (Reference SA6AL75SH) due to a potential defect affecting a subset of these devices. The problem involves the possible loss of primary segment material, which could expose the underlying stainless-steel braid wires. This catheter is used in cardiovascular procedures and was distributed worldwide to multiple countries including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, Taiwan, and the United Kingdom. All lot and serial numbers of this model with GTIN 00613994823953 are affected.
The recall document does not specify a remedy or recommended action for affected consumers.
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: 573 units Lot/code info: GTIN: 00613994823953 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.