CLASS III Device recall · Reported 17 Jun 2015 · FDA Enforcement Report
Relieva Flex Sinus Guide Catheter F recalled by Acclarent
Acclarent is recalling Relieva Flex Sinus Guide Catheter F-70, distributed in Texas. The recall was initiated on 28 Apr 2015 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1740-2015
- FDA event ID
- 71232
- Recalling firm
- Acclarent, Menlo Park, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Apr 2015
- FDA classified
- 9 Jun 2015
- Reported
- 17 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 28 Apr 2015 | Recall initiated by company | |
| 9 Jun 2015 | Classified by FDA | +42 days |
| 17 Jun 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Product as listed by the FDA
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. .
Where it was distributed
US in the state of Texas
Questions about this recall
Why was it recalled?
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Which lots are affected?
Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.
Where was it sold?
US in the state of Texas
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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