FDA Device recall Z-0356-2016
ProTrack Microcatheter
- FDA Device
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of ProTrack Microcatheter by Baylis Medical, citing microcatheter may have circumferential defects (cracks) along its shaft.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0356-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-28 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baylis Medical |
| Distribution | US |
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
Microcatheter may have circumferential defects (cracks) along its shaft.
Identifiers
| code_info | CIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614,…CIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614, CIFA240614, CIFB100714, CIFA100714, CIFA180814, CIFA080914, CIFA241014, CIFA221014, CIFA050115, CIFA210115, CIFA060215 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0356-2016%22
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