ProTrack Microcatheter — Class II medical device recall Z-0356-2016
Terminated recall by Baylis Medical Corp *, reported 2015-12-09, distributed nationwide. Microcatheter may have circumferential defects (cracks) along its shaft.
| Recall number | Z-0356-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baylis Medical Corp *, Montreal, Canada |
| Recall initiated | 2015-10-28 |
| Classified | 2015-12-01 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2016-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 433 units |
| Reason classes | packaging |
| Model numbers | CIC35-145, CIC38-145 |
Product
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
Reason for recall
Microcatheter may have circumferential defects (cracks) along its shaft.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0356-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.