Empower Introducer Sheath with Hydrophilic Coating 21F x… recallZ-1016-2022 · Freudenberg Medical, Llc · initiated Feb 21, 2022

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Freudenberg Medical, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

FDA root cause category: Process control

What the company is doing

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

Recall details

Recall number: Z-1016-2022
Status: Terminated
Initiated by the company: Feb 21, 2022
Recalling firm: Freudenberg Medical, Llc
Quantity: 13 units (US)
Product code: DYB
FDA submissions: K190628
Distribution: US distribution: GA, OH Foreign distribution: Netherlands

Product description

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

Code information (models, lots, serial numbers)

Lot Numbers: PD01, PD00013140 UDI: 00850004312001

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING 668782-100
Freudenberg Medical, LLC · Introducer, Catheter
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 89882).

Z-1017-2022 · Terminated
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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