CLASS II ONGOING Device recall · Reported 2 Nov 2022 · FDA Enforcement Report
Vortex MP Port Titanium Low Profile Implanted Port recalled
Angiodynamics is recalling Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and, distributed nationwide in the US. The recall was initiated on 20 Sep 2022 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-0132-2023
- FDA event ID
- 90924
- Recalling firm
- Angiodynamics, Queensbury, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Sep 2022
- FDA classified
- 25 Oct 2022
- Reported
- 2 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 20 Sep 2022 | Recall initiated by company | |
| 25 Oct 2022 | Classified by FDA | +35 days |
| 2 Nov 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling UPN: H787MPP5SAT0 Catalog Number: MP-P5SAT
Where it was distributed
US Nationwide distribution in the states of AZ, CA, DC, IN, PA.
Nationwide ArizonaCaliforniaDistrict of ColumbiaIndianaPennsylvania
Questions about this recall
Is Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and recalled?
Yes. Angiodynamics recalled Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and on 20 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-0132-2023.
Why was it recalled?
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.
Which lots are affected?
UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025
Where was it sold?
US Nationwide distribution in the states of AZ, CA, DC, IN, PA.
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.
More recalls from Angiodynamics
All 100| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Soft-Vu Angiographic Catheter, Headhunter , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft-Vu Angiographic Catheter, Cobra , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft-Vu Angiographic Catheter, Cobra , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |