Mini-Stick Max Coaxial Microintroducer Kit
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Mini-Stick Max Coaxial Microintroducer Kit | More than 10 numbers, contact manufacturer. | H965457541 H965457591 H965457501 H965457491 H965457511 H965457561 |
Issue
Angiodynamics, Inc., is conducting a medical device field safety corrective action (FSCA) to the end user level based on the non-conformance of a supplied component included within the Angiodynamics Mini Stick Max Coaxial Microintroducer Kit. This non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub.
Recall start date: January 30, 2024
Additional information
Details
Navilyst Medical, Inc.
26 Forest Street, Marlborough, Massachusetts, United States, 01752
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