CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit recalled
Ellex iScience is recalling ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, distributed nationwide in the US. The recall was initiated on 11 Jan 2018 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-0011-2019
- FDA event ID
- 80569
- Recalling firm
- Ellex iScience, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2018
- FDA classified
- 1 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jan 2018 | Recall initiated by company | |
| 1 Oct 2018 | Classified by FDA | +263 days |
| 10 Oct 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility failure found in one of the units in the lot.
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
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Where it was distributed
Distribution US nationwide and Switzerland.
Questions about this recall
Is ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use recalled?
Yes. Ellex iScience recalled ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use on 11 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-0011-2019.
Why was it recalled?
Sterility failure found in one of the units in the lot.
Which lots are affected?
Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108
Where was it sold?
Distribution US nationwide 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 21 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 | iTRACK250A Canaloplasty Microcatheter Kit recalled by Ellex iScience | Ellex iScience | Sterility | Nationwide |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | 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 | 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 |