courtlistener_docket
1 records
Insulet Corporation v. Mohammed Samara
2026-04-17
Federal docket 3:26-cv-02479 (casd); matched party 'Insulet Corporation'
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fda
14 records
FDA Recall: Insulet Corporation — Class I
20260422
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod ins | Product: Omnipod 5 Pods. Model/Catalog number: ...
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FDA Recall: Insulet Corporation — Class I
20240110
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery | Product: Omnipod 5 App (on compatible Android s...
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FDA Device Recall: Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3
2024-01-10
Class I — The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does...
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FDA Device Recall: Omnipod 5 Automated Insulin Delivery System
2023-09-27
Class II — An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from...
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FDA Recall: Insulet Corporation — Class I
20221123
The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a | Product: 18239: ASM Omnipod Dash PDM, insulin d...
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FDA Device Recall: 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Da
2022-11-23
Class I — The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a co...
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FDA Recall: Insulet Corporation — Class II
20210317
Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in | Product: Omnipod DASH Insulin Management System...
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FDA Device Recall: Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog N
2021-03-17
Class II — Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page ...
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FDA Device Recall: Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: P
2020-04-01
Class II — 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 calc...
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FDA Device Recall: Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM
2019-11-13
Class II — There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus hist...
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FDA Device Recall: OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usa
2015-12-23
Class I — Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
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FDA Device Recall: OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product U
2015-12-23
Class I — Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
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FDA Device Recall: OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catal
2015-09-16
Class I — OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver in...
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FDA Device Recall: OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalo
2015-09-16
Class I — OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver in...
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lobbying
3 records
Lobbying Firm: INSULET CORPORATION
Registered lobbying firm — Acton, MA — Medical device manufacturing, innovative medical technologies
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Lobbying Client: INSULET CORPORATION
Lobbied by PRIME POLICY GROUP — Medical device company that manufacturers Omnipod, an innovative tubeless insulin pump.
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Lobbying Client: INSULET CORPORATION
Lobbied by TODD STRATEGY GROUP — Medical device manufacturing, innovative medical technologies.
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nppes
1 records
ny_medicaid
1 records
NY Medicaid: INSULET CORPORATION
MEDICAL EQUIPMENT SUPPLIERS & DEALER | MCO | BILLERICA, OUT OF STATE
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SEC EDGAR
1 records
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