FDA Medical Device Recalls (openFDA)
Acclarent, Inc.: 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. .
- Recall number
- Z-1740-2015
- 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. .
- Status
- Terminated
- Initiated
- 2015-04-28
- Posted
- 2015-06-09
- Terminated
- 2015-06-10
- Reason
- Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
- 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
- 986
- Distribution
- US in the state of Texas
- Lot, serial or model codes
- Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KAM
- Firm FEI
- 3005172759
- 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