# China NMPA Product Recall - Detachable spring coil (Product name: Matrix²)

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/88b30f33-8d98-4cd1-b565-c02d30e25cb8/
Source feed: China

> China NMPA product recall for Detachable spring coil (Product name: Matrix²) by Boston Scientific Corporation published June 01, 2011. Recall level: . The National Medical Products Administration (NMPA) announced on June 1, 2011, a voluntary recall in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific Inc. is recalling its detachable coils.
- Company Name: Boston Scientific Corporation
- Publication Date: 2011-06-01
- Product Name: Detachable spring coil (Product name: Matrix²)
- Recall Reason: PGLA degradation occurred before the product's expiration date. No patient injury reports have been received related to this complaint, but there is a potential clinical risk of PGLA-coated foreign body embolism during implantation surgery.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: The National Medical Products Administration (NMPA) announced on June 1, 2011, a voluntary recall initiated by Boston Scientific International Medical Trade (Shanghai) Co., Ltd., for specific batches of its "Matrix2" detachable coils. The manufacturer is Boston Scientific Corporation, USA. The recall stemmed from the premature degradation of the PGLA (polyethylene glycol-polylactic acid) coating on the coils, which occurred before the products' expiration date. Two complaints confirmed this issue, though no patient injuries were reported. The primary concern identified was the potential for PGLA foreign body embolism if degraded material entered the circulatory system during implantation, posing a risk that could range from minor to a serious stroke, albeit with a very low likelihood of severe outcomes.

Under the oversight of the NMPA (formerly the State Food and Drug Administration), Boston Scientific implemented a recall plan. This involved identifying all 101 affected customers through shipping records, notifying them via various channels, and facilitating the return of the compromised products. The recall operation was largely completed by December 27, 2010, with 226 affected products returned from 25 customers. Provincial food and drug administrations were concurrently instructed to enhance their supervision and management of similar medical devices to ensure patient safety.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/