EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pedi
Summary
The FDA issued a Class II for EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutritio by Boston Scientific Corporation. Reason: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the .
Details
Source
Device Recall
External ID
Z-1513-2024
Action Date
2024-04-17
Status
Ongoing
Category
device
Product Description
EndoVive 20Fr Push Safety PEG Kit w/ENFit (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: M00509011
Lot/Code Info: GTIN: 08714729880417 Lot Numbers: 32257549, 32257552, 32267521, 32270820, 32358475, 32358478, 32367048, 32374780, 32374781, 32385061, 32506053, 32506054, 32515036, 32531791, 32545183, 32545184, 32623024, 32802227, 32802228, 32810934, 32810935, 32958981, 32958982 ,32968819, 32970723, 33080372,33080373,33087966 ,33209008
Quantity Affected: 2726 units
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
Distribution
Worldwide distribution - US Nationwide and the country of Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-20
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1513-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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