CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
Vein Irrigation Cannula with blunt tip recalled by LivaNova USA
LivaNova USA is recalling Vein Irrigation Cannula with blunt tip, distributed in 44 states. The recall was initiated on 24 Apr 2020 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-2463-2020
- FDA event ID
- 85623
- Recalling firm
- LivaNova USA, Arvada, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2020
- FDA classified
- 26 Jun 2020
- Reported
- 8 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 24 Apr 2020 | Recall initiated by company | |
| 26 Jun 2020 | Classified by FDA | +63 days |
| 8 Jul 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
Where it was distributed
US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)
AlaskaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasLouisianaMassachusettsMarylandMaine
Questions about this recall
Is Vein Irrigation Cannula with blunt tip recalled?
Yes. LivaNova USA recalled Vein Irrigation Cannula with blunt tip on 24 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2463-2020.
Why was it recalled?
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
Which lots are affected?
LOT 2004900018
Where was it sold?
US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)
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 LivaNova USA
All 42| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System recalled | LivaNova USA | Other | 41 states |
| Device | CLASS II | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part recalled | LivaNova USA | Other | 41 states |
| Device | CLASS II | VNS Therapy¿ SenTiva DUO" recalled by LivaNova USA | LivaNova USA | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA recalled | LivaNova USA | Lead & Heavy Metals | 7 states |
| Device | CLASS II | VNS Therapy Sentiva DUO # 1000-D recalled by LivaNova USA | LivaNova USA | Other | 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 |