CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
3///8 Y Conn, Strl recalled by LivaNova USA
LivaNova USA is recalling 3///8 Y Conn, Strl, 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-2459-2020
- 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
- Other Reasons
- Device type
- Other Medical 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
XXX
Product as listed by the FDA
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
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 3///8 Y Conn, Strl recalled?
Yes. LivaNova USA recalled 3///8 Y Conn, Strl on 24 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2459-2020.
Why was it recalled?
XXX
Which lots are affected?
LOT2004300008
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.
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|---|---|---|---|---|---|
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