Acclarent, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1740-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: April 28, 2015

Date Posted: June 17, 2015

Recall Number: Z-1740-2015

Event ID: 71232

Reason for Recall:

Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.

Status: Terminated

Product Quantity: 986

Code Information:

Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.

Distribution Pattern:

US in the state of Texas

Voluntary or Mandated:

Voluntary: Firm initiated