FDA Medical Device Recalls (openFDA)
Intersect ENT, Inc.: Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
- Recall number
- Z-0458-2023
- Recalling firm
- Intersect ENT, Inc.
- Product
- Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
- Status
- Open, Classified
- Initiated
- 2022-10-21
- Posted
- 2022-12-08
- Terminated
- not on file
- Reason
- Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
- Root cause
- Error in labeling
- Action
- On 10/21/22, recall notices from Medtronic/Intersect ENT were sent to customers who were asked to do the following: 1) Identify, quarantine, and return all unused affected products to Medtronic. 2) Complete and return the customer confirmation form. 3) Distribute the recall notice to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. The following contact information was provided: rs.xentproductfeedback@medtronic.com and CustomerService@intersectent.com
- Quantity
- 611 units
- Distribution
- US Nationwide distribution including in the states of NC, IL, KS, OR, WI, TX, FL, MN, WY, UT, NY, CA, NJ, OK, MD, HI, MT, TN, MO, IA, MA, AZ, GA, LA, ID, SC, WA, SD, ND, CO, NV.
- Lot, serial or model codes
- REF: 60044, UDI-DI: M927600440, Lot: 22041901
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OWO
- Firm FEI
- 3008301917
- Firm city
- Menlo Park
- Firm state
- CA
- 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