Z-1275-2016Class I

Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US...

Name: Z-1275-2016 Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US...
Creator: Vascular Solutions, Inc.
Published: 2016-03-04
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2016-03-04 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product... on 2016-03-04. FDA classified it as Class I and gives the reason as "Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and...". 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-1275-2016
Classification: Class I
Status: Terminated
Initiated: 2016-03-04
Posted: 2016-04-07
Terminated: 2016-10-19
Recalling firm: Vascular Solutions LLC
Product: Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Reason for recall: Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Consignees were sent on 3/4/2016 via first class mail a Vascular Solutions "Urgent Medical Device Recall" letter dated March 3, 2016. The letter described the problem and the product involved in the recall. It included the "Immediate Action Required of Customer / User" which instructed the customer to identify the product, remove it from inventory, place it in a secure area, and complete and return the VSI Account Inventory Form to the Customer Service Department.
Quantity in commerce: 5283
Distribution: Nationwide Distribution in the states of AL, AR, CA, CO, DE, FL, GA, ID, IL IN, IA,KY, LA, MD, MA, MI, MO, NE,NV, NH, NY, NC, OH, PA, SD, TN, TX, UT, VA, WA, and WV. OUS: Ireland
Product codes and lots: Lot numbers: 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, and 583286.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1275-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1275-2016	Class I	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-07

Product code DTL

K122301Class IIGuardian II Hemostasis Valve Guardian II Nc Hemostasis ValveVascular Solutions Zerusa , Ltd. / cleared 2012-09-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)