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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ev3-inc/c2566295-84d0-42ea-80a8-349ace8acbba/
Source feed: China

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

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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 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: Ev3 Inc., a medical device manufacturer, initiated a voluntary recall for its PowerCross PTA Dilatation Catheter, as reported by China's National Medical Products Administration (NMPA) on December 22, 2016. The recall stemmed from a discovery, made during routine product inspections and formally reported on November 28, 2016, that the catheter's outer shaft experienced squeezing and deformation at the proximal connection of the balloon. This defect could restrict the internal lumen, potentially leading to critical issues such as the balloon failing to inflate, slow deflation, or complete inability to deflate after inflation. An internal investigation revealed the root cause as a manufacturing process deviation: a new operator failed to adhere to standard procedures during the balloon pleating process, inserting the product too far into the machine. Although Ev3 Inc. promptly initiated this recall under the NMPA's regulatory framework, it was confirmed that none of the affected PowerCross catheters were ever imported into or sold within China. Therefore, while provincial regulatory bodies were informed for oversight, no specific corrective actions were necessary for the Chinese market. The primary impact of this recall was on products distributed in other regions, notably the United States.

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