The Recall Desk
HighFDA (Devices)·Z-0779-2022·Announced 2022-03-23

Boston Scientific JAGTOME RX Device Recalled for Sterile Barrier Breach

Boston Scientific is recalling 14 JAGTOME RX medical devices worldwide due to a sterile barrier breach that compromises the device's 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 recall for a compromised sterile barrier on a medical device, which constitutes a risk-of-harm product. No illnesses or injuries have been reported, making this a precautionary recall based on the theoretical hazard of device sterility compromise.

Plain-English summary

Boston Scientific Corporation is recalling 14 units of the JAGTOME RX 49-30-450-035 medical device (Material Number M00573030, Lot Number 27951184). The recall is due to a sterile barrier breach that compromises the device's sterility.

The sterile barrier of a medical device is designed to maintain sterile conditions. A breach of this barrier means the device may not have maintained its sterility as intended.

The affected devices have been distributed worldwide, including throughout the United States and to numerous countries including Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland, and the United Arab Emirates, among others.

The recalled product

Product
JAGTOME RX 49-30-450-035 Material Number: M00573030
Manufacturer
Boston Scientific Corporation
Category
Medical Device
Hazard
  • sterile-barrier-breach
  • contamination

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: 27951184 GTIN: 8714729776741

Distribution

Distributed nationwide across the United States.

Related recalls

Same category