Z-1390-2018Class II

Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive...

Name: Z-1390-2018 Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2018-01-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-01-18 / Terminated

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems on 2018-01-18. FDA classified it as Class II and gives the reason as "NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1390-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-18
Posted: 2018-04-17
Terminated: 2018-09-21
Recalling firm: Boston Scientific Corporation
Product: Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Product code: OEQ Angiography/Angioplasty Kit
Reason for recall: NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.
FDA root cause: Under Investigation by firm
Action: Recall Notifications were delivered by Fed Express. Consignees instructed to segregate and return all affected devices to Angiodynamics and complete and return the Reply Verification Tracking Form.
Quantity in commerce: 38 units
Distribution: Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
Product codes and lots: Lot Numbers: 5284422 5286610 5283649 5290525 5286542

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1390-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1390-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17

Product code OEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)