Medtronic Midas Rex Legend High Speed Pneumatic System
FDA device recall Z-0278-05 · posted 2004-12-04 · Terminated
Recall details
- Recalling firm
- Power Surgical Solutions
- Reason for recall
- Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported.
- Action taken
- The firm initiated the recall via letter on November 11, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- HBB
- Quantity affected
- 1432 units
- Distribution
- Nationwide and to the following foreign countries; Australia; Japan; Canada, China; Netherlands; Columbia; Mexico; Argentina; Sweden; Poland; Spain; Germany; Great Britan; Chile; Switzerland; Venezuel
- Date initiated
- 2004-11-11
- Date posted
- 2004-12-04
- Date terminated
- 2005-09-20
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM (K020069) | Medtronic Midas Rex | 2002-03-18 |