The Recall Desk
HighFDA (Devices)·Z-0776-2022·Announced 2022-03-23

Medical Device Sterile Barrier Breach: JAGTOME RX Recall

Boston Scientific is recalling JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units 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 recall involving a compromised sterile barrier on a medical device, which presents a risk of harm if the device is used. No illnesses, hospitalizations, or injuries have been reported. Per the rubric, a risk-of-harm product where injury has not been reported scores 3 (High).

Plain-English summary

Boston Scientific Corporation is recalling JAGTOME RX medical devices (Material Number M00573070) due to a compromised sterile barrier. The recall involves 163 units with lot numbers 27737251, 27970819, 28289451, 27821545, and 28019275.

The sterile barrier protects the device from contamination before use. When the sterile barrier is compromised, the device may become contaminated, potentially causing infection if implanted or used clinically. No infections or adverse events have been reported to date.

The affected devices were distributed worldwide, including throughout the United States and internationally to countries including Australia, Austria, Belgium, Canada, China, France, Germany, Japan, and many others. Consumers who have received these devices should consult with their healthcare provider immediately to determine if they have an affected device and whether any action is needed.

The recalled product

Product
JAGTOME RX 44-30-450-035 Material Number: M00573070
Manufacturer
Boston Scientific Corporation
Category
Medical Device
Hazard
  • sterile-barrier-breach
  • contamination-risk
  • infection-risk

Distribution

Distributed nationwide across the United States.

Related recalls

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