Recall record at a glance
| Official record | Z-1517-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Boston Scientific Corporation |
| Report date | Apr 17, 2024 |
| Recall initiation date | Feb 20, 2024 |
| Quantity | 13 units (Japan) |
| Location | Marlborough, MA, United States |
Official product description
EndoVive 20 Fr Safety PEG Push w/ENFit 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: M00509191
Why the product was 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
Distribution information
Worldwide distribution - US Nationwide and the country of Japan.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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