FDA Device recall Z-2620-2016
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of…
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of… by Cook, citing increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a dev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2620-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-15 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | US |
Product
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Reason
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Identifiers
| code_info | All Lots. Catalog prefixes / suffixes NPAS-/-SST Catalog/product number; Global/order number NPAS-100-HC-NT-U-SST…All Lots. Catalog prefixes / suffixes NPAS-/-SST Catalog/product number; Global/order number NPAS-100-HC-NT-U-SST G52963 NPAS-100-HC-U-SST G52962 NPAS-101-HC-NT-U-SST G23067 NPAS-101-HC-U-SST G23066 NPAS-104-HC-NT-JWG-U-SST G52966 NPAS-104-HC-NT-U-SST G52965 NPAS-104-HC-U-SST G52964 NPAS-105-HC-NT-U-SST G52967 NPAS-108-HC-NT-U-SST G25516 NPAS-120-HC-NT-U-SST G25517 NSSW-4.0-18-NPAS-100-HC-SST G34253 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2620-2016%22
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