Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Reported: October 1, 2025 Initiated: August 28, 2025 #Z-2618-2025
Product Description
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Reason for Recall
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 156 units
- Distribution
- US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);. Recalled by Boston Scientific Corporation. Units affected: 156 units.
Why was this product recalled? ▼
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 1, 2025. Severity: Moderate. Recall number: Z-2618-2025.
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