CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
Encore 26 Inflation Device, Material Numbers (UPN): H74904526011 recalled
Boston Scientific is recalling Encore 26 Inflation Device, Material Numbers (UPN): H74904526011. The recall was initiated on 5 Aug 2025 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-2533-2025
- FDA event ID
- 97396
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2025
- FDA classified
- 5 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 5 Aug 2025 | Recall initiated by company | |
| 5 Sep 2025 | Classified by FDA | +31 days |
| 17 Sep 2025 | 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
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Product as listed by the FDA
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Which lots are affected?
1. H74904526011, GTIN 8714729177029, Lot Numbers: 34915076, 35065978; 2. H74904526052, GTIN 8714729127062, Lot Numbers: 34915078, 34915220; 3. M0067101140, GTIN 8714729755814, Lot Numbers: 34892421; 4. M001151050, GTIN 8714729183624, Lot Numbers: 34966934; 5. M001151062, GTIN 8714729137542, Lot Numbers: 34873498; 6. M00566670, GTIN 8714729755241, Lot Numbers: 35045668.
Where was it sold?
Worldwide distribution.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 97396This product is part of a recall event; the main page for the event is NephroMax Kit, Material Numbers (UPN): M0062101180 recalled.
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