Contract Medical International GmbH recalled 2,500 Fortress Introducer Sheath Systems on July 30, 2025. Units may have incorrect pouch labeling, leading to potential use of the wrong device version. Patients and healthcare providers should stop using the product immediately.
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Contract Medical International GmbH or your healthcare provider for instructions. Notification method: E-Mail
The recalled product is the Fortress Introducer Sheath System, model number 386594. It consists of a 6F Straight 45cm device. Units were distributed worldwide, including across multiple U.S. states.
The product may have been packaged with an incorrect pouch label. This mislabeling lists the reference number and unique device identifier of the 4F version instead of the 6F version.
There are no reported injuries or incidents related to this recall. The nature of the mislabeling presents a high risk if the incorrect device is used.
Stop using the Fortress Introducer Sheath System immediately. Contact Contract Medical International GmbH or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2532-2025.
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