Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.
FDA device recall Z-1456-05 · posted 2005-08-31 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.
- Action taken
- Consignees were advised by recall letter dated July 25, 2005 and requested to return all units on hand.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 115
- Distribution
- Nationwide, Germany, Italy, Netherlands, Spain and Sweden.
- Date initiated
- 2005-07-15
- Date posted
- 2005-08-31
- Date terminated
- 2007-02-07
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.