The Recall Desk
HighFDA (Devices)·Z-1513-2024·Announced 2024-04-17

EndoVive 20Fr Push Safety PEG Kit Recall Due to Blocked Lumen Risk

Boston Scientific is recalling the EndoVive 20Fr PEG feeding kit due to blockage in the barb connector that can prevent proper placement. The blockage may lead to prolonged procedures, bleeding, gastric leakage, and aspiration risk.

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: This is an FDA Class II recall of a risk-of-harm medical device where malfunction could lead to serious complications including bleeding and aspiration during a medical procedure. No illnesses or injuries have been reported in the source text, classifying the hazard as theoretical rather than confirmed.

Plain-English summary

Boston Scientific Corporation is recalling 2,726 units of the EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2) due to a blockage in the barb connector that prevents proper advancement of the guidewire during placement. The product is a feeding tube kit indicated for enteral nutrition in pediatric and adult patients who cannot consume nutrition by conventional means.

The blockage in the barb connector's lumen can prevent the guidewire from advancing through the feeding tube during placement. When this occurs, the procedure time may be significantly prolonged, and the device may need to be exchanged for another unit.

When device exchange becomes necessary, patients may experience a cascade of serious complications including additional intervention to close the puncture site, internal bleeding, leakage of gastric contents, and aspiration.

The affected units were distributed worldwide, including throughout the United States and Japan. Patients or healthcare providers who have this device should contact Boston Scientific for instructions on how to proceed.

The recalled product

Product
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
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Enteral feeding tube / PEG
Hazard
Affected units
2,726

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 (20)

  • GTIN: 08714729880417 Lot Numbers: 32257549
  • 32257552
  • 32267521
  • 32270820
  • 32358475
  • 32358478
  • 32367048
  • 32374780
  • 32374781
  • 32385061
  • 32506053
  • 32506054
  • 32515036
  • 32531791
  • 32545183
  • 32545184
  • 32623024
  • 32802227
  • 32802228
  • 32810934

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.

See all 5 products in this recall →

Related recalls

Same manufacturer · Boston Scientific Corporation

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Same hazard · blocked lumen

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