Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
FDA Recall Z-1017-2022 · Posted None
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Recalling FirmFreudenberg Medical, Llc
Recall StatusTerminated
Product CodeDYB
Date Initiated2022-02-21
Date Terminated2024-04-18
Product Quantity8 units (OUS)
Reason for Recall
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to
peripheral ischemia
Firm Action
Boston Scientific issued letter dated Feb 2022 -Model 8782 EMPOWER" Introducer Sheath Product Retrieval and MODULAR ATP Clinical Study Temporary Enrollment Suspension. Letter states reason, health risk and action to take:
1. Immediately segregate all affected product to ensure that it will not be used.
2. Your local Field Clinical Engineer will retrieve and return affected product and assist you in completing the enclosed Reply Verification Tracking Form.
3. Do not enroll new patients into the MODULAR ATP Clinical Study until further communication from Boston Scientific is received.
4. Continue following enrolled patients per protocol.
5. Communicate with your IRB/ EC as required by your site.
BSC recognizes the impact of communications on both you and your patients. We are committed to transparent communication with healthcare professionals to ensure you have timely, relevant information for managing your patients and conduct this clinical study with the highest quality and ethical standards. If you have further questions, please contact Ken Stein, MD, Sr. Vice President and Chief Medical Officer, Boston Scientific Rhythm Management
Root Cause
Process control
Distribution Pattern
US distribution: GA, OH Foreign distribution: Netherlands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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