Recalls / —
—#165247
Product
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
- FDA product code
- DQY — Catheter, Percutaneous
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K153729
- Affected lot / code info
- Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941
Why it was recalled
There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device would be used, which could potentially prolong a procedure.
Root cause (FDA determination)
Employee error
Action the firm took
On April 12, 2018, the recalling firm sent Urgent Medical Device Voluntary Customer Communication, Immediate Action Required letters with instructions to return a response form. The letter provided directions for use.
Recalling firm
- Firm
- Stryker Neurovascular
- Address
- 47900 Bayside Pkwy, Fremont, California 94538-6515
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-04-11
- Posted by FDA
- 2018-07-28
- Terminated
- 2021-04-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165247. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.