VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-l
FDA device recall Z-0114-2017 · posted 2016-10-27 · Terminated
Recall details
- Recalling firm
- Sequent Medical Inc
- 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.
- Action taken
- Sequent 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 618 units
- Distribution
- 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, Sloven
- Date initiated
- 2016-09-23
- Date posted
- 2016-10-27
- Date terminated
- 2017-05-01
- Location
- Aliso Viejo, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIA MICROCATHETER, VIA PLUS MICROCATHETER (K132652) | Sequent Medical, Inc. | 2013-12-20 |