Z-1016-2022Class II

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

Name: Z-1016-2022 Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Creator: Freudenberg Medical, Llc
Published: 2022-02-21
License: https://open.fda.gov/license/

Freudenberg Medical, LLC / initiated 2022-02-21 / Terminated / root cause: manufacturing process

FDA source

Freudenberg Medical, Llc began a recall of Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) on 2022-02-21. FDA classified it as Class II and gives the reason as "Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1016-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-21
Posted: 2022-04-28
Terminated: 2024-04-18
Recalling firm: Freudenberg Medical, LLC
Product: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Product code: DYB Introducer, Catheter
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
Root cause tag: manufacturing process
FDA 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 in commerce: 13 units (US)
Distribution: US distribution: GA, OH Foreign distribution: Netherlands
Product codes and lots: Lot Numbers: PD01, PD00013140 UDI: 00850004312001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1016-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1016-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-28
Z-1017-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-28

Product code DYB

K190628Class IIFlexSeal Introducer Sheath with Hydrophilic CoatingFreudenberg Medical Mis, Inc. / cleared 2019-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)