Z-0458-2023Class II

Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

Name: Z-0458-2023 Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Creator: Intersect ENT, Inc.
Published: 2022-10-21
License: https://open.fda.gov/license/

Intersect ENT / initiated 2022-10-21 / Open, Classified / root cause: labeling and UDI

FDA source

Intersect ENT, Inc. began a recall of Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044 on 2022-10-21. FDA classified it as Class II and gives the reason as "Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0458-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-21
Posted: 2022-12-08
Recalling firm: Intersect ENT
Product: Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Product code: OWO Drug-Eluting Sinus Stent
Reason for recall: Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Root cause tag: labeling and UDI
FDA 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: [email protected] and [email protected]
Quantity in commerce: 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.
Product codes and lots: REF: 60044, UDI-DI: M927600440, Lot: 22041901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0458-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0458-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-08

Product code OWO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)