Z-1458-2010

Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number...

Name: Z-1458-2010 Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number...
Creator: Abbott Diabetes Care, Inc.
Published: 2009-04-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-04-14 / Terminated / root cause: manufacturing process

FDA source

Abbott Diabetes Care, Inc. began a recall of Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care... on 2009-04-14. The reason FDA records is "Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1458-2010
Status: Terminated
Initiated: 2009-04-14
Posted: 2010-04-30
Terminated: 2011-03-31
Recalling firm: Abbott Medical
Product: Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
Product code: MDS Sensor, Glucose, Invasive
Reason for recall: Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Notification letters were issued to FreeStyle Navigator customers via certified mail and notification was posted on the Abbott Diabetes Care's Website. Customers were notified of the potential issue and actions to take: 1) if moisture is observed in the FreeStyle Navigator transmitter now or at any time, discontinue use of the transmitter and call Abbott Diabetes Care Customer Care at 1-800-418-6427 and 2) if a loss of connection is encountered or if your results are not reliable or are inconsistent with how you feel, consult your User's Guide for troubleshooting guidelines. If the issue is not resolved, call Abbott Diabetes Care Customer Care at 1-800-418-6421. For outside-of-US accounts, the firm's regional offices will distribute notices to identified customers in the appropriate language.
Quantity in commerce: 5,449 of total units
Distribution: Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.
Product codes and lots: Abbott Item # PRT 03415-010 with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M0878 or 01M3018. Kit Serial numbers beginning with: BAAH 067 BAAH 093 or BAAH 107 or BAAH 156 or BAAH 200 or BAAH 207 or BAAH 275 or BAAH 290 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 288 and followed by a five (5) digit number.

Product code MDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)