CLASS II ONGOING Device recall · Reported 23 Mar 2022 · FDA Enforcement Report
Jagtome Revolution RX 39-30-260-025 Material Number: M00584260 recalled
Boston Scientific is recalling Jagtome Revolution RX 39-30-260-025 Material Number: M00584260, distributed nationwide in the US. The recall was initiated on 22 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0767-2022
- FDA event ID
- 89468
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Dec 2021
- FDA classified
- 11 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2021 | Recall initiated by company | |
| 11 Mar 2022 | Classified by FDA | +79 days |
| 23 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility of device is compromised due to a sterile barrier breach
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
Questions about this recall
Is Jagtome Revolution RX 39-30-260-025 Material Number: M00584260 recalled?
Yes. Boston Scientific recalled Jagtome Revolution RX 39-30-260-025 Material Number: M00584260 on 22 Dec 2021. The recall is Class II and its status is Ongoing. Recall number Z-0767-2022.
Why was it recalled?
Sterility of device is compromised due to a sterile barrier breach
Which lots are affected?
Lot Numbers: Batch 27482863 27532553 27602969 27652583 27723139 27758892 27796835 27846707 27899139 27966498 28021411 GTIN: 8714729953258
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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