PEG feeding tube with blocked connector may impede placement procedure
Boston Scientific's EndoVive 20Fr PEG Kit may have a blocked connector that prevents the guidewire from advancing during placement, potentially causing complications including bleeding and aspiration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device with potential for serious complications (bleeding, aspiration) due to manufacturing defect, but no reported illnesses or injuries to date.
Plain-English summary
Boston Scientific Corporation is recalling 1,475 units of the EndoVive 20Fr Push Standard PEG Kit (Box 2) due to a manufacturing defect affecting the barb connector. These kits are used to place feeding tubes directly into the stomach for patients who cannot eat normally.
The recall involves devices with lot numbers 32151880, 32247311, and 32810232, which have been distributed in the United States and Japan. The defect involves a blocked lumen in the barb connector that may prevent the guidewire from advancing during the tube placement procedure.
If the guidewire becomes blocked during placement, the procedure may take longer and require exchanging the device for a replacement. This delay and additional manipulation could lead to serious complications, including puncture site bleeding, leakage of stomach contents, and aspiration (when stomach contents enter the airway).
Affected patients or healthcare providers should contact Boston Scientific if they have received one of these devices. The manufacturer recommends not using affected devices and returning them for replacement.
The recalled product
- Product
- 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
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,475
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 (3)
- GTIN: 08714729285205 Lot Numbers: 32151880
- 32247311
- 32810232
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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