The Recall Desk
HighFDA (Devices)·Z-0769-2022·Announced 2022-03-23

JAGTOME RX medical device recalled for sterile barrier breach

Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.

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 medical device recall for a sterile barrier breach. Although this hazard poses a risk of patient harm, the source text does not report any illnesses, injuries, or hospitalizations, placing it at the high-risk level per the rubric.

Plain-English summary

Boston Scientific Corporation is recalling 367 units of the JAGTOME RX 39-20-450-025 medical device (Material Number: M00573090). The device has been distributed worldwide, including throughout the United States and internationally to countries such as Australia, Canada, China, France, Germany, Japan, Korea, and others.

The recall is due to a sterile barrier breach that compromises the sterility of the device.

The affected lot numbers are Batch 27632862 and Batch 27855805 (GTIN: 8714729776550). Patients and healthcare providers with this device should contact Boston Scientific Corporation for further guidance.

The recalled product

Product
JAGTOME RX 39-20-450-025 Material Number: M00573090
Manufacturer
Boston Scientific Corporation
Category
Medical Device
Hazard
  • sterile-barrier-breach
  • infection-risk

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)

  • Lot Numbers: Batch 27632862 27855805 GTIN: 8714729776550

Distribution

Distributed nationwide across the United States.

Related recalls

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