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U.S. Department of Health and Human Services

Class 2 Device Recall VIA 27 Microcatheters

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 Class 2 Device Recall VIA 27 Microcatheterssee related information
Date Initiated by FirmSeptember 23, 2016
Date PostedOctober 27, 2016
Recall Status1 Terminated 3 on May 01, 2017
Recall NumberZ-0114-2017
Recall Event ID 75211
510(K)NumberK132652 
Product Classification Catheter, continuous flush - Product Code KRA
ProductVIA 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).
Code Information 16031101, 16042901, 16051201, 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16012901, 16040801, 16041501, 16052603, 16061701
FEI Number 3008423090
Recalling Firm/
Manufacturer		 Sequent Medical Inc
11 Columbia
Aliso Viejo CA 92656-1460
For Additional Information Contact
949-923-9400
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionSequent Medical sent an Urgent Medical Device Recall letter dated September 23, 2016, to all affected customers. The letter informed customers that Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. The letter informs the customers of the risk to health and actions to be taken. Customers were instructed to send all confirmation forms and questions to www.customerserviceus@sequentmedical.com. Customers with questions should call (949) 830-9600x130. For questions regarding this recall call 949-923-9400.
Quantity in Commerce618 units
DistributionWorldwide 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,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KRA
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