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RIGIFLEX II
BOSTON SCIENTIFIC CORPORATION · Model M00554510 · UDI-DI 08714729719113
PID
Prescription
3
510(k) clearances
143
Adverse events (1 deaths)
1
Recalls
7
Facilities
Description
Single Use Achalasia Ballon Dilator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-25 | Covidien, LLC | Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.