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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Angiodynamics, Inc.: Mini Stick Max Guidewire Introducers Recalled Due to Potential Blockage

Agency Publication Date: March 21, 2024
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Summary

Angiodynamics, Inc. is recalling 19,423 Mini Stick Max guidewire introducers used in surgical procedures to help insert wires into the vascular system. A manufacturing defect has caused some devices to have blockages (voids) in the internal path of the sheath hub, which can prevent the guidewire from passing through. This defect requires doctors to stop the procedure and exchange the faulty device, leading to surgical delays and potential complications for the patient. These devices were distributed worldwide between January 30, 2024, and the present.

Risk

The internal pathway of the introducer hub may contain physical obstructions that block the guidewire from moving forward during surgery. This can cause a delay in critical medical procedures while medical staff locate and prepare a replacement device, increasing the time a patient is under surgical conditions.

What You Should Do

  1. Check your surgical inventory for Mini Stick Max introducers with the following Catalog Numbers: 45-749, 45-750, 45-751, 45-752, 45-754, 45-756, 45-758, 45-759, 45-762, 45-765, 45-767, 45-774, 45-775, 45-776, or 45-781.
  2. Verify the Lot Number on the individual product packaging against the affected list, which includes specific lots such as 5805056, 5784035, 5789981, 5805057, 5784134, 5796084, 5805060, 5789493, 5788541, 5790681, 5787806, 5787804, 5790680, 5787840, and 5791593 (refer to the full product list for all 100+ affected lot numbers).
  3. Immediately stop using and quarantine any affected devices to ensure they are not used in surgical procedures.
  4. Contact your healthcare provider or Angiodynamics, Inc. directly at 1-888-463-6332 for specific instructions regarding the return or exchange of these devices.
  5. Contact the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions or need to report an incident.

Your Remedy Options

๐Ÿ“‹Other Action

Device exchange and procedure delay mitigation.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG
Model / REF:
45-749
UPC Codes:
15051684022927
Lot Numbers:
5805056
Product: MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG
Model / REF:
45-750
UPC Codes:
15051684022934
Lot Numbers:
5784035
5784036
5784136
5787837
5788554
5788555
5789978
5790448
5790449
5791589
5791590
5791591
5797460
5797461
5798838
5799613
5799623
5800399
5804390
5806116
Product: MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG
Model / REF:
45-751
UPC Codes:
15051684022941
Lot Numbers:
5789981
5789983
5791592
5791595
5795873
5797462
Product: MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG
Model / REF:
45-752
UPC Codes:
15051684022958
Lot Numbers:
5805057
5806119
Product: MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG
Model / REF:
45-754
UPC Codes:
15051684022972
Lot Numbers:
5784134
5787807
5787808
5787809
5787810
5789980
5790676
5800402
5803531
Product: MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG
Model / REF:
45-756
UPC Codes:
15051684022996
Lot Numbers:
5796084
5796085
5796086
5796087
5796088
5796089
5796090
5796659
5796660
5796661
5796662
5796663
5796666
5797456
5797465
5798836
5798841
5798842
5799620
5800404
5803526
5804396
Product: MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG
Model / REF:
45-758
UPC Codes:
15051684023016
Lot Numbers:
5805060
Product: MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG
Model / REF:
45-759
UPC Codes:
15051684023023
Lot Numbers:
5789493
5789494
5789495
5789496
5789497
5791596
5791597
5791598
5793392
5793393
5794602
5794603
5794604
5794605
5794606
5795874
5795875
5797457
5797458
5797466
5797467
5798837
5798843
5798844
Product: MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG
Model / REF:
45-762
UPC Codes:
15051684023054
Lot Numbers:
5788541
5789982
5791594
5794608
5797468
5798845
Product: MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG
Model / REF:
45-765
UPC Codes:
15051684023085
Lot Numbers:
5790681
5795961
5800479
5803518
5805067
Product: MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG (Alternative)
Model / REF:
45-767
UPC Codes:
15051684023108
Lot Numbers:
5787806
5790679
5795962
5803521
5806728
Product: MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG
Model / REF:
45-774
UPC Codes:
15051684023177
Lot Numbers:
5787804
5787805
5800397
5803524
5805070
5805071
Product: MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG
Model / REF:
45-775
UPC Codes:
15051684023184
Lot Numbers:
5790680
5798831
5806100
Product: MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG
Model / REF:
45-776
UPC Codes:
15051684023191
Lot Numbers:
5787840
5803520
5805069
Product: MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG
Model / REF:
45-781
UPC Codes:
15051684023238
Lot Numbers:
5791593
5794613
5797470

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94035
Status: Active
Manufacturer: Angiodynamics, Inc.
Sold By: Angiodynamics, Inc.; Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 15 products (104 units; 4366 units; 959 units; 58 units; 1676 units; 5176 units; 15 units; 5840 units; 600 units; 130 units; 200 units; 155 units; 65 units; 40 units; 39 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.