Z-1740-2015Class III

RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to...

Name: Z-1740-2015 RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to...
Creator: Acclarent, Inc.
Published: 2015-04-28
License: https://open.fda.gov/license/

Acclarent Inc / initiated 2015-04-28 / Terminated / root cause: manufacturing process

FDA source

Acclarent, Inc. began a recall of RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for... on 2015-04-28. FDA classified it as Class III and gives the reason as "Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date". 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-1740-2015
Classification: Class III
Status: Terminated
Initiated: 2015-04-28
Posted: 2015-06-09
Terminated: 2015-06-10
Recalling firm: Acclarent Inc
Product: RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
Product code: KAM Cannula, Sinus
Reason for recall: Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Acclarent sent an Urgent Medical Device Recall letter dated May 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that if the affected catheter is still in inventory, it should be isolated and returned to Acclarent per instructions. Questions should be addressed to Gabriel Alfageme, Field Action Coordinator at 1-650-687-5398.
Quantity in commerce: 986
Distribution: US in the state of Texas
Product codes and lots: Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1740-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1740-2015	Class III	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09

Product code KAM

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)