The Recall Desk
HighFDA (Devices)·Z-0771-2022·Announced 2022-03-23

Medical Device Recall: Boston Scientific JAGTOME RX Sterile Barrier Breach

Boston Scientific is recalling 98 units of the JAGTOME RX 39-30-260-025 medical device due to compromised sterile barrier that affects device sterility. Units were distributed worldwide.

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 involving compromised sterile barrier integrity, representing potential risk of device-related infection; no illnesses or injuries have been reported in the source material.

Plain-English summary

Boston Scientific Corporation is recalling the JAGTOME RX 39-30-260-025 medical device (Material Number M00573100). The recall involves 98 units distributed worldwide to the United States and numerous international countries, including Australia, Austria, Belgium, Canada, China, France, Germany, Japan, Korea, and others. The affected lot number is 27857328 (GTIN: 8714729776529).

The reason for the recall is that the sterile barrier of the device is compromised. This means the device's sterility has been affected and can no longer be assured.

The recalled product

Product
JAGTOME RX 39-30-260-025 Material Number: M00573100
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: 27857328 GTIN: 8714729776529

Distribution

Distributed nationwide across the United States.

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