Insulet Corporation: Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).

Recall number

Z-1553-2020

Recalling firm

Insulet Corporation

Product

Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).

Status

Terminated

Initiated

2020-02-13

Posted

not on file

Terminated

2021-09-14

Reason

In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia.

Root cause

Software design

Action

On February 14, 2020, the firm notified all affected customers of the recall via Urgent Medical Device Correction letters through email and post; the customer communication was also posted on the firm's website. Customers were informed of the product issue and provided with the following precautions: 1. Always enter a current BG into the Bolus Calculator before giving a bolus. This will replace the old BG value and ensure an accurate dose is calculated based on the current BG. 2. Total Bolus should always be the sum of the Meal Bolus and Correction Bolus. The firm will be making a software update to the next version of Omnipod DASH PDM which will provide a solution for this issue and is expected to be available starting March 2020. The firm will be voluntarily providing a replacement PDM to all existing Omnipod DASH users. The firm will contact users directly when replacements are ready to be shipped. Customers may visit www.omnipod.com for updated information on PDM replacement timing. In the meantime, the firm states that customers may continue using their current Omnipod DASH PDM provided you follow the above precautions. If you have any questions regarding the information provided in this Medical Device Correction, please contact 1-800-581-6359.

Quantity

32756 (US), 1420 (International)

Distribution

US Nationwide distribution. Foreign distribution to Italy, Netherlands, and United Kingdom.

Lot, serial or model codes

Software Version 1.0.50 and earlier  Lots L000120 L000121 L000122 L000123 L000124 L000125 L000126 L000127 L000128 L000129 L000130 L000131 L000132 L000133 L000134 L000135 L000136 L000137 L000138 L000139 L000140 L000141 L000142 L000143 L000144 L000145 L000146 L000147 L000148 L000149 L000150 L000151 L000152 L000153 L000154 L000155 L000156 L000157 L000158 L000159 L000160 L000161 L000162 L000163 L000164 L000165 L000166 L000167 L000168 L000169 L000170 L000171 L000172 L000173 L000174 L000175 L000176 L000177 L000178 L000179 L000180 L000181 L000182 L000183 L000184 L000185 L000186 L000187 L000188 L000189 L000190 L000191 L000192 L000193 L000194 L000195 L000196 L000197 L000198 L000199 L000213 L000214 L000204

510(k) numbers

["K192659"]

PMA numbers

not on file

Product code

LZG

Firm FEI

3014585508

Firm city

Acton

Firm state

MA

Firm country

not on file

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

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