Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- United StatesARROW10801902210408
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
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-09-08 | VAI | Voluntary action indicated | ARROW INTERNATIONAL, LLC | 2 |
| 2023-07-14 | NAI | No action indicated | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 0 |
| 2023-07-14 | NAI | No action indicated | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 0 |
| 2021-06-16 | NAI | No action indicated | Arrow International, Inc. (subsidiary of Teleflex, Inc.) | 0 |
| 2021-06-16 | NAI | No action indicated | Arrow International, Inc. (subsidiary of Teleflex, Inc.) | 0 |
| 2016-06-20 | VAI | Voluntary action indicated | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 1 |
| 2016-06-20 | VAI | Voluntary action indicated | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 1 |
| 2016-03-17 | NAI | No action indicated | Arrow International CR, a.s. | 0 |
| 2016-03-10 | VAI | Voluntary action indicated | Arrow Internacional De Chihuahua SA de CV | 3 |
| 2014-09-24 | VAI | Voluntary action indicated | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 0 |
| 2014-09-24 | VAI | Voluntary action indicated | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 0 |
| 2014-08-22 | VAI | Voluntary action indicated | Arrow International, Inc. (subsidiary of Teleflex, Inc.) | 10 |
| 2014-08-22 | VAI | Voluntary action indicated | Arrow International, Inc. (subsidiary of Teleflex, Inc.) | 10 |
| 2014-05-08 | NAI | No action indicated | Arrow International CR, a.s. | 0 |
| 2013-12-18 | NAI | No action indicated | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 0 |
| 2013-12-18 | NAI | No action indicated | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 0 |
| 2013-11-07 | VAI | Voluntary action indicated | Arrow International, Inc. (subsidiary of Teleflex, Inc.) | 1 |
| 2013-11-07 | VAI | Voluntary action indicated | Arrow International, Inc. (subsidiary of Teleflex, Inc.) | 1 |
| 2013-02-07 | NAI | No action indicated | Arrow International CR, a.s. | 0 |
| 2012-02-01 | VAI | Voluntary action indicated | Arrow International, Inc. (subsidiary of Teleflex, Inc.) | 1 |
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