Z-0114-2017 Class II Terminated
FDA device recall Z-0114-2017 was initiated by Sequent Medical Inc on September 23, 2016 and is designated Class II. Reason for recall: Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. The recall status is terminated (terminated May 1, 2017). Affected quantity: 618 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2016
- Initiation Date
- September 23, 2016
- Termination Date
- May 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 618 units
Product Description
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).
Reason for Recall
Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.
Distribution Pattern
Worldwide Distribution - US including NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, TN, WV and Internationally to Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark,
Code Information
16031101, 16042901, 16051201, 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16012901, 16040801, 16041501, 16052603, 16061701