# China NMPA Product Recall - Insulin infusion pump; insulin injection pump; insulin pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/cfa0f181-9f28-44cf-bf01-df9d3db2efc8/
Source feed: China

> China NMPA product recall for Insulin infusion pump; insulin injection pump; insulin pump by Medtronic (Shanghai) Management Co., Ltd. published July 04, 2019. Recall level: Level 3 Recall. On July 4, 2019, Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Level III recall of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. is voluntarily recalling insulin infusion pumps, insulin injection pumps, and insulin pumps.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2019-07-04
- Product Name: Insulin infusion pump; insulin injection pump; insulin pump
- Recall Level: Level 3 Recall
- Recall Reason: The product in question poses a potential cybersecurity risk. Unauthorized personnel could use specialized technology and equipment to send radio frequency signals to nearby insulin pumps, thereby modifying pump settings and controlling insulin infusion dosage. This cybersecurity issue could potentially trigger hypoglycemia or hyperglycemia and diabetic ketoacidosis.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: On July 4, 2019, Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Level III recall of its insulin infusion pumps, insulin injection pumps, and insulin pumps, as announced by the National Medical Products Administration (NMPA). The action was taken due to identified potential cybersecurity risks associated with these devices. The pumps are designed to communicate with auxiliary devices using radio frequency (RF) technology, which presented a vulnerability where unauthorized individuals could potentially send RF signals to alter pump settings and control insulin infusion dosage. This issue could lead to severe health consequences for patients, including hypoglycemia from an overdose of insulin or hyperglycemia and diabetic ketoacidosis from an insufficient dose. While Medtronic had not received any complaints regarding unauthorized modifications, the company proactively launched a security notification and recall based on the extreme possibility of malicious hacking, classifying the patient safety risk at Level 2. The recall applies to products with specific registration certificate numbers, with detailed information available in an attached recall event report form.

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2/