FDA Medical Device Recalls (openFDA)
Medtronic MiniMed: Paradigm Model 511 and 512 Insulin Infusion Pumps
- Recall number
- Z-0168-04
- Recalling firm
- Medtronic MiniMed
- Product
- Paradigm Model 511 and 512 Insulin Infusion Pumps
- Status
- Terminated
- Initiated
- 2003-08-29
- Posted
- 2003-11-27
- Terminated
- 2005-09-02
- Reason
- Water ingresses into the device when in prolonged contact with water causing device to malfunction.
- Root cause
- Other
- Action
- 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.
- Quantity
- Approximately 61,000 patients
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Codes are irrelevant
- 510(k) numbers
- ["K001829"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28