Z-1702-2016Class II

AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use...

Name: Z-1702-2016 AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2016-03-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-03-21 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit... on 2016-03-21. FDA classified it as Class II and gives the reason as "Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow...". 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-1702-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-21
Posted: 2016-05-20
Terminated: 2017-09-18
Recalling firm: Boston Scientific Corporation
Product: AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: On 3/21/2016, AngioDynamics sent recall notification packages (dated 3/21/2016) to the consignees via Federal Express. Consignees are instructed to follow the instructions provided on the Maquet Cardiopulmonary recall letter (dated 2/23/2016) and return the Reply Verification Tracking Form, provided in the recall notification.
Quantity in commerce: Domestic: 377 kits
Distribution: Nationwide Distribution.
Product codes and lots: Lot Numbers: 4876386, 4889699, 4889700, 4898652, 4902111, 4902117, 4906576, 4941511, 4941511D, 4943459, 4955686, 4956929, 4969475, 4975493, 4991710, 4999714.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1702-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1701-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-20
Z-1702-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-20

Product code DWE

K142607Class IIAngioVac CircuitAngiodynamics / cleared 2014-12-11

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)