CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report
Mini Stick Max 4F Std .018 NI/TU Echo 75" Pg-Used recalled
Angiodynamics is recalling Mini Stick Max 4F Std .018 NI/TU Echo 75" Pg-Used for the percutaneous introduction of a, distributed nationwide in the US. The recall was initiated on 30 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1335-2024
- FDA event ID
- 94035
- Recalling firm
- Angiodynamics, Queensbury, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jan 2024
- FDA classified
- 21 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 30 Jan 2024 | Recall initiated by company | |
| 21 Mar 2024 | Classified by FDA | +51 days |
| 27 Mar 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Product as listed by the FDA
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
Questions about this recall
Is Mini Stick Max 4F Std .018 NI/TU Echo 75" Pg-Used for the percutaneous introduction of a recalled?
Yes. Angiodynamics recalled Mini Stick Max 4F Std .018 NI/TU Echo 75" Pg-Used for the percutaneous introduction of a on 30 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1335-2024.
Why was it recalled?
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Which lots are affected?
UDI: 15051684022934 UPN: H965457501 Lot Number: 5784035 5784036 5784136 5787837 5788554 5788555 5789978 5790448 5790449 5791589 5791590 5791591 5797460 5797461 5798838 5799613 5799623 5800399 5804390 5806116
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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