CLASS II ONGOING Device recall · Reported 10 Aug 2022 · FDA Enforcement Report
EkoSonic Kit TZ The EkoSonic Endovascular Device is recalled
Boston Scientific is recalling EkoSonic Kit TZ The EkoSonic Endovascular Device is packaged as a kit that includes both, distributed in 10 states. The recall was initiated on 25 May 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-1492-2022
- FDA event ID
- 90528
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 May 2022
- FDA classified
- 1 Aug 2022
- Reported
- 10 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 25 May 2022 | Recall initiated by company | |
| 1 Aug 2022 | Classified by FDA | +68 days |
| 10 Aug 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may be mislabeled.
Product as listed by the FDA
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Where it was distributed
US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
CaliforniaConnecticutGeorgiaIowaIllinoisIndianaNew YorkOhioTexasWyoming
Questions about this recall
Is EkoSonic Kit TZ The EkoSonic Endovascular Device is packaged as a kit that includes both recalled?
Yes. Boston Scientific recalled EkoSonic Kit TZ The EkoSonic Endovascular Device is packaged as a kit that includes both on 25 May 2022. The recall is Class II and its status is Ongoing. Recall number Z-1492-2022.
Why was it recalled?
Product may be mislabeled.
Which lots are affected?
UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234
Where was it sold?
US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
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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