Corrective Action CROSS™ Hemi Shoulder

It has come to our attention that the magnetic buckle used in the CROSS™ Hemi Shoulder, item no. 28717, should not be used by individuals with a pacemaker or implantable cardioverter defibrillator (ICD1). This contraindication is currently not included in the product’s Instructions for Use (IFU), and we will therefore update the IFU accordingly.

This update concerns CROSS™ Hemi Shoulder with LOT no. 52285 and 52686.

Please note: This action is being taken as a precaution and is not the result of any reported adverse events.

Why are we updating the IFU?

New information indicates that the magnetic buckle (the chest-positioned buckle labeled “1”) may cause interference with pacemakers or ICDs. Although modern pacemakers and ICDs are generally resistant to magnetic interference, we recommend avoiding the use of CROSS™ Hemi Shoulder in these cases, out of caution. 

Updated IFU will be available with the product as soon as possible. The IFU on the online product page has been updated.

For any questions regarding this matter, please contact regulatory@camp.se