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Recall of Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of 200 mm only)
According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biotronik Australia Pty Ltd.
What is this?
A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
Learn more about the data here-
Type of Event
Recall
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Event ID
RC-2015-RN-00440-1
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Event Risk Class
Class I
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Event Initiated Date
2015-05-25
- Event Country
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Event Source
DHTGA
- Event Source URL
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Notes / Alerts
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia. -
Extra notes in the data
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Reason
Biotronik has received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of our pulsar-18 and pulsar-35 peripheral self-expanding nitinol stent systems. potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent. stents that have already been implanted are not affected as the issue occurs during deployment of the stent.
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Action
Users are advised to discontinue any further use of the affected stock and remove them from their inventory. A sales representative will contact customers to collect the affected stock. This action has been closed-out on 02/12/2016.
Device
Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of...
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Model / Serial
Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of 200 mm only) Pulsar-35Product Codes: 379921, 379941, 379926, 379946, 379931, 379951Specific LotsARTG number: 169368 Pulsar-18 Product Codes: 366812, 366832, 366817, 366837, 366822, 366842, 366827, 366847Specific LotsARTG number: 142025
- Manufacturer
Manufacturer
- Manufacturer Parent Company (2017)
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Manufacturer comment
Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
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Source
DHTGA