CLASS II ONGOING Device recall · Reported 17 Apr 2024 · FDA Enforcement Report
EndoVive Push Standard PEG Kit (Box -Indicated recalled
Boston Scientific is recalling EndoVive Push Standard PEG Kit (Box -Indicated for enteral nutrition directly into the, distributed nationwide in the US. The recall was initiated on 20 Feb 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-1516-2024
- FDA event ID
- 94165
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Feb 2024
- FDA classified
- 11 Apr 2024
- Reported
- 17 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 20 Feb 2024 | Recall initiated by company | |
| 11 Apr 2024 | Classified by FDA | +51 days |
| 17 Apr 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
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00568211
Where it was distributed
Worldwide distribution - US Nationwide and the country of Japan.
Questions about this recall
Is EndoVive Push Standard PEG Kit (Box -Indicated for enteral nutrition directly into the recalled?
Yes. Boston Scientific recalled EndoVive Push Standard PEG Kit (Box -Indicated for enteral nutrition directly into the on 20 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1516-2024.
Why was it recalled?
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Which lots are affected?
GTIN: 08714729285205 Lot Numbers: 32151880, 32247311, 32810232
Where was it sold?
Worldwide distribution - US Nationwide and the country of Japan.
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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