Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 27, 2013
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.
Risk that air may be introduced into the device which may lead to an air embolism.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Vascular Solutions, Inc. recalled Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardio… - a critical-severity action.
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardio… was recalled by Vascular Solutions, Inc. in March 27, 2013. Reason: Risk that air may be introduced into the device which may lead to an air embolism.. Check the official notice for the remedy. Verify recall #Z-0955-2013 with the FDA Devices before acting.
The recall
Vascular Solutions, Inc. issued this critical-severity FDA Devices recall-Risk that air may be introduced into the device which may lead to an air embolism..
- Critical
- severity level
- 80K units
- affected scope
- Class I
- classification
- March 27, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0955-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0955-2013) was formally reported on March 27, 2013, with the manufacturer initiating the action on February 27, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Vascular Solutions, Inc. is listed as the recalling firm, operating out of Maple Grove, MN. Federal records list the affected scope as 79,869.
The documented reason for this recall is: Risk that air may be introduced into the device which may lead to an air embolism. Distribution data in the federal record shows the product reached: Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT , VT, VA, WA, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
79,869
Related Recalls
6
3 from same agency
Product description
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.
Reason for recall
Risk that air may be introduced into the device which may lead to an air embolism.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0955-2013 |
| Date reported | March 27, 2013 |
| Date initiated | February 27, 2013 |
| Recalling firm | Vascular Solutions, Inc. |
| Firm location | Maple Grove, MN |
| Affected scope | 79,869 |
| Distribution | Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI, and coun… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0955-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.. Recalled by Vascular Solutions, Inc.. Units affected: 79,869.
Why was this product recalled? ▼
Risk that air may be introduced into the device which may lead to an air embolism.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2013. Severity: Critical. Recall number: Z-0955-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI, and countries of GREECE, DENMARK, AUSTRIA, UNITED KINGDOM, SWITZERLAND, IRELAND, INDIA, TURKEY, POLAND, HUNGARY, ITALY, EGYPT, KOREA, PORTUGAL HONG KONG, GERMANY, SPAIN, MEXICO, SWEDEN, NORWAY SLOVENIA, NETHERLANDS, and BELGIUM..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0955-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 27, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.