Paradigm Model 511 and 512 Insulin Infusion Pumps
FDA device recall Z-0168-04 · posted 2003-11-27 · Terminated
Recall details
- Recalling firm
- Medtronic MiniMed
- Reason for recall
- Water ingresses into the device when in prolonged contact with water causing device to malfunction.
- Action taken
- The firm sent notifications to all pump users of record, all distributors and all certified pump trainers indications that the pumps should not be immersed in water. Canadian users were contacted by Medtronic Canada.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- Approximately 61,000 patients
- Distribution
- Nationwide and Canada
- Date initiated
- 2003-08-29
- Date posted
- 2003-11-27
- Date terminated
- 2005-09-02
- Location
- Northridge, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINIMED PARADIGM INSULIN PUMP, MODEL 511 (K001829) | Minimed, Inc. | 2000-08-18 |