Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Reported: July 12, 2017 Initiated: June 1, 2017 #Z-2674-2017
Product Description
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Reason for Recall
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 32 units
- Distribution
- MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340. Recalled by Boston Scientific Corporation. Units affected: 32 units.
Why was this product recalled? ▼
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2017. Severity: Moderate. Recall number: Z-2674-2017.
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