Field Safety Notices about Capio SLIM Open Access suture collection unit Capio SLIM Open Access suture collection unit (Box 5), Capio Open Access suture collection unit (Box 4), Capio Value suture collection unit (Box 4), Capio RP suture collection unit, uphold LITE Capio SLIM vaginal support system, Pinnacle repair kit for the anterior pelvic Pinnacle LITTLE posterior with Capio SLIM repair kit for the pelvic floor

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Boston Scientific Corporation.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

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  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
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