| | Class 2 Device Recall Encore" 26 Inflation Device |  |
| Date Initiated by Firm | August 05, 2025 |
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| Date Posted | September 05, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2533-2025 |
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| Recall Event ID |
97396 |
| Product Classification |
Syringe, Balloon Inflation, Exempt - Product Code PTM
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| Product | 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) |
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| Code Information |
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.
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| FEI Number |
3002095335
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Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
|
| For Additional Information Contact | Clara Johnson
763-494-1133 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Boston Scientific issued an Urgent Medical Device Removal notice to it consignees on 8/5/2025 via letter delivered using a traceable means. The notice explained the issue. potential adverse health consequences associated with use in each device and requested the following instructions be followed:
1. Further distribution or use of any remaining devices affected by this removal should cease immediately.
Do NOT use affected devices and remove those devices from your facility s inventory.
Segregate the units in a secure place until they can be returned to Boston Scientific.
2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device.
3. Forward this notice to any healthcare professional from your organization and to any
facilities where affected devices have been transferred, including hospitals or sites within your network.
If you are a distributor, this notice must be forwarded to your customers to ensure
notification of this device removal is carried out to the end-user level.
4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed
instructions on page four of the notice
5. Return affected devices. The entire Encore 26 Advantage Kit, NephroMax Kit, or
UroMax Ultra Kit must be returned in order to be reimbursed.
For questions, please contact your local sales representative. |
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| Quantity in Commerce | 39739 units |
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| Distribution | Worldwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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