Recalls / —
—#31252
Product
Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029
- FDA product code
- DQO — Catheter, Intravascular, Diagnostic
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K932092
- Affected lot / code info
- Lot Number: 160760 Expiration Date: 2006-12
Why it was recalled
Catheter distal tip may separate
Root cause (FDA determination)
Other
Action the firm took
Medtronic notified sales representatives/distributors on 1/14/04 via telephone and email and requested to retrieve affected product from the hospitals and return it to Danvers, MA. A script and effectiveness document was provided and to be reviewed with the hospital.
Recalling firm
- Firm
- Medtronic, Inc.
- Address
- 37a Cherry Hill Dr, Danvers, Massachusetts 01923-2565
Distribution
- Distribution pattern
- NC, WA
Timeline
- Recall initiated
- 2004-01-14
- Posted by FDA
- 2004-02-10
- Terminated
- 2004-11-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #31252. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.