Recalls / —
—#160218
Product
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
- FDA product code
- NRY — Catheter, Thrombus Retriever
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K113260, K132641
- Affected lot / code info
- UPN/Model No. 80052; Lot 63034
Why it was recalled
Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
Root cause (FDA determination)
Packaging process control
Action the firm took
The affected consignees will be notified via letter sent a courier beginning 11/28/17. A response form has been provided which customers have been asked to complete, and correct affected product is being requested.
Recalling firm
- Firm
- Stryker Neurovascular
- Address
- 47900 Bayside Pkwy, Fremont, California 94538-6515
Distribution
- Distribution pattern
- OUS only - NL, FR, IT, DE, BE
Timeline
- Recall initiated
- 2017-11-28
- Terminated
- 2020-04-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160218. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.