EndoVive 20 Fr Feeding Tube May Obstruct During Placement
Boston Scientific is recalling EndoVive 20 Fr feeding tubes due to potential blockage during placement that may prevent guidewire advancement. This could lead to procedure complications including bleeding, gastric leakage, or aspiration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II with potential for serious harm including aspiration and bleeding, but no reported illnesses or injuries. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling EndoVive 20 Fr Safety PEG Push with ENFit Kit (Box 2) feeding tubes. These medical devices are designed for enteral nutrition delivery directly into the stomach for patients (both pediatric and adult) who cannot consume food through conventional means.
The recall addresses a potential blockage in the barb connector lumen that may prevent the guidewire from advancing through the feeding tube during placement. This obstruction could extend the placement procedure and require the device to be exchanged.
If the blockage prevents proper placement and the device must be replaced, a cascade of complications may occur. These include the need for additional intervention to close the stomach puncture site, as well as potential complications such as bleeding, leakage of gastric contents, and aspiration.
The affected product is identified by UPN M00509191 with Lot Number 32234291 (GTIN: 08714729880691). The device has been distributed worldwide including US nationwide and Japan. Patients and healthcare providers with questions should contact Boston Scientific.
The recalled product
- Product
- 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
- Manufacturer
- Boston Scientific Corporation
- Hazard
- obstruction
- bleeding
- aspiration
- leakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 08714729880691 Lot Numbers: 32234291
Distribution
Distributed nationwide across the United States.
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