FDA Medical Device Recalls (openFDA)
Freudenberg Medical, Llc: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
- Recall number
- Z-1017-2022
- Recalling firm
- Freudenberg Medical, Llc
- Product
- Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
- Status
- Terminated
- Initiated
- 2022-02-21
- Posted
- not on file
- Terminated
- 2024-04-18
- Reason
- Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
- Root cause
- Process control
- 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
- Quantity
- 8 units (OUS)
- Distribution
- US distribution: GA, OH Foreign distribution: Netherlands
- Lot, serial or model codes
- Lot Numbers: PD02, PD00013142 UDI: 00802526618000
- 510(k) numbers
- ["K190628"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1000121130
- Firm city
- Jeffersonville
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28