AngioVac Circuit Pack (Tandem Packs), REF/Catalog No.… recallZ-1702-2016 · Angiodynamics Inc. (Navilyst Medical Inc.) · initiated Mar 21, 2016
Class II Terminated All recalls posted in May 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics Inc. (Navilyst Medical Inc.) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Environmental control
What the company is doing
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.
Recall details
- Recall number
- Z-1702-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 21, 2016
- Posted by the FDA
- May 20, 2016
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Quantity
- Domestic: 377 kits
- Product code
- DWE
- FDA submissions
- K142607
- Distribution
- Nationwide Distribution.
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers: 4876386, 4889699, 4889700, 4898652, 4902111, 4902117, 4906576, 4941511, 4941511D, 4943459, 4955686, 4956929, 4969475, 4975493, 4991710, 4999714.
Other devices under the same FDA submission
3 devices cleared under K142607 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AngioVac 25188Angiodynamics, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 deaths2 reports
- AngioVac 25199Angiodynamics, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS1 report
- AngioVac H965252810Navilyst Medical, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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