Device 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.
Z-0356-2016
Product summary
- Event
- Event 72539
- Status
- Terminated
- Classification
- Class II
- Quantity
- 433 units
- Official record key
device-enforcement:Z-0356-2016
Official wording
Reason: Microcatheter may have circumferential defects (cracks) along its shaft.
Code information: CIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614, CIFA240614, CIFB100714, CIFA100714, CIFA180814, CIFA080914, CIFA241014, CIFA221014, CIFA050115, CIFA210115, CIFA060215
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Microcatheter may have circumferential defects (cracks) along its shaft.