Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2016-09-16 | Z-0055-2017 | Class I | Terminated | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico and outside the US to include: Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom. | 11,670 units total | clearance family |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-10-10 | OAI | Official action indicated | Vascular Solutions, LLC (A Subsidiary of Teleflex) | 3 |
| 2021-11-16 | NAI | No action indicated | Vascular Solutions, LLC (A Subsidiary of Teleflex) | 0 |
| 2017-09-21 | NAI | No action indicated | Vascular Solutions, LLC (A Subsidiary of Teleflex) | 0 |
| 2014-07-15 | NAI | No action indicated | Vascular Solutions, LLC (A Subsidiary of Teleflex) | 0 |
| 2013-05-20 | NAI | No action indicated | Vascular Solutions, LLC (A Subsidiary of Teleflex) | 0 |
| 2013-04-08 | NAI | No action indicated | Vascular Solutions, LLC (A Subsidiary of Teleflex) | 0 |
| 2011-06-02 | VAI | Voluntary action indicated | Vascular Solutions, LLC (A Subsidiary of Teleflex) | 0 |
| 2010-05-10 | VAI | Voluntary action indicated | Vascular Solutions, LLC (A Subsidiary of Teleflex) | 3 |
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