Bard and Daig Steerable Diagnostic EP Catheter Recall for Sterility Breach

Stryker Sustainability Solutions initiated a Type II medical device recall for Bard Dynamic Deca and Daig Livewire Steerable Diagnostic EP Catheters after receiving complaints about compromised sterile barriers on the chevron seal side of the primary Tyvek pouch. The recall affects multiple lots across three product catalogue numbers (201101, 401904, 401575). Healthcare facilities performing cardiac electrophysiology procedures using these devices should immediately identify affected inventory, quarantine product, and contact the manufacturer to determine next steps for replacement or return.

Affected parties including hospitals, cardiac ablation centers, and electrophysiology labs must review their inventory records for the specified catheter models and lot numbers, discontinue use of any potentially compromised devices, and coordinate with Stryker Sustainability Solutions for resolution. While the recall is classified as Type II (moderate potential harm rather than serious or life-threatening), the sterility breach represents a serious patient safety concern given the invasive nature of cardiac procedures where these devices are used.