PEG Feeding Tube Kit Recalled for Blocked Lumen Preventing Guidewire Advancement
Boston Scientific is recalling 572 EndoVive PEG feeding tube kits due to a blocked lumen in the barb connector that may prevent guidewire advancement during placement, potentially requiring device exchange and increasing risk of complications.
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 a manufacturing defect in the barb connector that may prevent proper guidewire advancement. Potential complications include aspiration, bleeding, and gastric content leakage. No illnesses or injuries have been reported. Per the rubric, with no reported harm and theoretical hazards, a Class II device scores as High (3).
Plain-English summary
Boston Scientific Corporation is recalling EndoVive 20Fr Push Standard PEG kits with ENFit connectors. The affected product has lot numbers 32162452, 32370861, and 32714500 and was distributed nationwide in the United States and in Japan. A total of 572 units are involved.
The barb connector in the affected kits may have a blocked lumen that prevents the guidewire from advancing through the feeding tube during placement. If blockage occurs, the procedure may be prolonged and require device exchange, potentially leading to additional interventions to close the puncture site, bleeding, leakage of gastric contents, and aspiration.
EndoVive PEG kits are indicated to provide enteral nutrition directly into the stomach for pediatric and adult patients unable to consume nutrition by conventional means. This recall affects patients who may have received the affected device or those scheduled for placement with affected lot numbers.
Patients and healthcare providers with affected devices should contact Boston Scientific Corporation for guidance on replacement or monitoring. Providers should review placement records to identify patients with affected lot numbers and determine appropriate follow-up.
The recalled product
- Product
- EndoVive 20Fr Push Standard 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: M00509051
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 572
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: 08714729880493 Lot Numbers: 32162452
- 32370861
- 32714500
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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