China NMPA Product Recall - Afterloader HDR Brachytherapy Afterloader

Varian Medical Systems (China) Co., Ltd. initiated a voluntary Class II medical device recall, formally reported to the National Medical Products Administration (NMPA) and the Beijing Municipal Drug Administration on July 9, 2019. The recall pertains to their HDR Brachytherapy Afterloader (Registration No. 20173331129) due to defective 17G stainless steel interstitial needles (part numbers GM11009510, GM11009520, GM11009530).

The primary concern is tip breakage of these needles, with reports of tips detaching before, during, or after patient treatment. In one case, two needle tips remained in a patient’s prostate, requiring prolonged anesthesia, though no adverse health effects were reported. The root cause was identified as a manufacturing defect: a polishing process introduced around 2016 corroded the weld securing the needle tip, making it susceptible to fracture. Affected batches include R43, S46, T11, T15, T28, T39, T48, and U13.

As required actions, Varian issued Stop Order PA1902 to halt shipments of affected products, recalling 263 units of specific batches sold in China. The company distributed two field safety notices (Revision A and B) globally, instructing users to discontinue use of the affected needles and return them for a refund. Varian is actively investigating new manufacturing processes and has committed to suspending shipments of stainless steel interstitial needles until a robust technical solution is developed, while also offering alternative titanium alloy needles to customers.