# China NMPA Product Recall - Delivery catheter (C315HIS type)

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/fd632e39-4691-45d4-bd96-3ace2176584b/
Source feed: China

> China NMPA product recall for Delivery catheter (C315HIS type) by Medtronic (Shanghai) Management Co., Ltd. published December 13, 2021. Recall level: Level 2 Recall. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its C315HIS deliv

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. voluntarily recalls delivery catheters.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2021-12-13
- Product Name: Delivery catheter (C315HIS type)
- Recall Level: Level 2 Recall
- Recall Reason: Some electrode leads cannot pass through the C315HIS delivery catheter. If an electrode lead cannot pass through the delivery catheter during the implantation procedure, a new delivery catheter will be required to complete the implantation, which may delay the implantation procedure.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its C315HIS delivery catheters, as announced by the National Medical Products Administration (NMPA) on December 13, 2021. The recall stems from an identified issue where certain Medtronic electrode leads are unable to pass through specific batches of the C315HIS delivery catheter. This malfunction could potentially delay implantation surgery if a new catheter is required during a procedure. The affected products are specifically from three batches of the C315HIS delivery catheter (Registration Certificate No.: 20153033120). Medtronic reported no patient injuries or adverse events worldwide related to this problem at the time of the recall. The company's action is limited to the retrieval of unused delivery catheters from the identified batches. No measures or patient management recommendations have been issued for delivery catheters already utilized in surgical procedures. This voluntary recall demonstrates Medtronic's adherence to regulatory standards set by the NMPA, ensuring product safety and quality within the medical device industry.

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