# China NMPA Product Recall - PTA dilation catheter (trade name: PowerCross)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ev3-inc/41921c63-696a-4cd3-a0e9-6c24075fb211/
Source feed: China

> China NMPA product recall for PTA dilation catheter (trade name: PowerCross) by ev3, Inc. published December 22, 2016. Recall level: . Manufacturer Ev3 Inc. initiated a voluntary recall for its PowerCross PTA Dilatation Catheter (NMPA 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ev3 Inc. is recalling its PTA dilator catheter (trade name: PowerCross).
- Company Name: ev3, Inc.
- Publication Date: 2016-12-22
- Product Name: PTA dilation catheter (trade name: PowerCross)
- Recall Reason: During routine inspections of end-of-life products, engineers discovered that the outer shaft of the catheter (e.g., outer layers of DWG-812312, DWG-812313, DWG-812314) was compressed and deformed at the proximal connection of the balloon. This compression and deformation narrowed the lumen used for the passage of saline/contrast agents during balloon inflation. Test results indicated that this narrowing could lead to incomplete inflation, slow deflation, or failure to deflate after inflation. The investigation revealed that a new operator failed to follow the procedures outlined in MP-703589, inserting the PowerCross product too far into the pleating and folding machine during the balloon pleating process. The affected products included all devices handled by this new operator during the pleating and folding process within the identified timeframe.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: ev3, Inc.
- Summary: Manufacturer Ev3 Inc. initiated a voluntary recall for its PowerCross PTA Dilatation Catheter (NMPA registration CFDA (Imported) 2012 No. 3770813 (Revised)) following the discovery of a manufacturing defect. Reported to the National Medical Products Administration (NMPA) by Covidien International Trading (Shanghai) Co., Ltd. on November 28, 2016, this action addresses a significant issue where the catheter’s outer shaft was squeezed and deformed at the proximal connection of the balloon.

Routine product inspections revealed that this deformation caused a narrowing of the internal lumen, potentially leading to critical failures such as the balloon not inflating, slowly deflating, or failing to deflate after inflation. An investigation traced the root cause to a new operator who failed to follow standard operating procedures (MP-703589), incorrectly inserting the product too far into a pleating and folding machine during manufacturing.

While Ev3 Inc. undertook the global voluntary recall for affected batches under NMPA oversight, the company confirmed that none of the defective products were imported into or sold within China. Consequently, no specific product retrieval or corrective actions were required in the Chinese market. However, provincial regulatory bodies were requested to enhance their supervision of similar products.

Company: https://www.globalkeysolutions.net/companies/ev3-inc/044d5c39-18df-428e-8958-30fee776b063/