The Recall Desk
HighFDA (Devices)·Z-0760-2022·Announced 2022-03-23

Hydratome RX 44-20MM medical device recalled for sterile barrier breach

Boston Scientific is recalling 254 units of the Hydratome RX 44-20MM medical device worldwide due to a compromised sterile barrier that may affect 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 recall involving a confirmed sterile barrier breach on a medical device. While the compromised sterility poses a potential risk of contamination, no illnesses or injuries have been reported in the source material.

Plain-English summary

Boston Scientific Corporation is recalling 254 units of the Hydratome RX 44-20MM medical device (Material Number M00583060). The device was distributed worldwide, including throughout the United States and to numerous countries including Australia, Austria, Belgium, Canada, China, France, Germany, Japan, Korea, and others.

The recall is due to a compromised sterile barrier on the device. The sterile barrier breach may result in loss of device sterility, creating a potential risk if the device is used. This is classified as an FDA Class II recall.

The affected units are identified by lot numbers Batch 27442309 and Batch 28020415 (GTIN 8714729755210).

The recalled product

Product
HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Manufacturer
Boston Scientific Corporation
Category
Medical Device
Hazard
  • sterile-barrier-breach
  • contamination-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 27442309 28020415 GTIN: 8714729755210

Distribution

Distributed nationwide across the United States.

Related recalls

Same category