CLASS II Device recall · Reported 10 Sep 2014 · FDA Enforcement Report
iTRACK250A Canaloplasty Microcatheter Kit recalled by Ellex iScience
Ellex iScience is recalling iTRACK250A Canaloplasty Microcatheter Kit, distributed nationwide in the US. The recall was initiated on 6 Aug 2014 and the FDA has classified it as Class II.
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-2590-2014
- FDA event ID
- 69021
- Recalling firm
- Ellex iScience, Menlo Park, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2014
- FDA classified
- 4 Sep 2014
- Reported
- 10 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 6 Aug 2014 | Recall initiated by company | |
| 4 Sep 2014 | Classified by FDA | +29 days |
| 10 Sep 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot may not have been properly sealed, resulting in a non-sterile device.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Where it was distributed
Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
Questions about this recall
Why was it recalled?
One lot may not have been properly sealed, resulting in a non-sterile device.
Which lots are affected?
Lot number 1404-03; Expiration: March 31, 2016
Where was it sold?
Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Ellex iScience
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit recalled | Ellex iScience | Sterility | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |