Z-0287-2009

NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile...

Name: Z-0287-2009 NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile...
Creator: Navilyst Medical
Published: 2008-08-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-08-06 / Terminated / root cause: manufacturing process

FDA source

Navilyst Medical began a recall of NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200... on 2008-08-06. The reason FDA records is "Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0287-2009
Status: Terminated
Initiated: 2008-08-06
Posted: 2008-11-09
Terminated: 2009-06-16
Recalling firm: Boston Scientific Corporation
Product: NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston Scientific Corporation/NAMIC Technology Center/Glens Falls, New York 12801. Angiographic Manifolds are intended for use in fluid management and/or invasive pressure monitoring systems. Procedures in which angiographic manifold may be used include hemodynamic pressure monitoring and intra-arterial and intravenous administration of water based solutions or radiographic contrast media.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 8/12/08, Navilyst Medical sent a fax and phoned the sole domestic hospital account that had received the affected units. Navilyst Medical instructed the consignee to immediately locate, segregate, and quarantine the units. The hospital consignee confirmed that all units were still in their control and that they will maintain them in quarantine awaiting return to Navilyst Medical. The sole international account, Boston Scientific in Ireland was notified of the problem on 8/06/08. This was followed up with an Urgent Medical Device Recall Letter and Verification Form sent via FedEx on 8/20/08.
Quantity in commerce: Domestic - 20 units; Foreign - 16,200 bulk units
Distribution: Worldwide Distribution --- USA including state of MO and country of Ireland.
Product codes and lots: UPN/Material #H749601902540, and Lot/Batch # 1280052 (domestic product), Lot/Batch #s and 1275834, 1276658, and 1278843 (foreign)

Product code DTZ

K782095Class IIStopcocks, ManifoldsNamic / cleared 1979-01-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)