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2530 BALLOON CONTROLLER

HANS RUDOLPH, INC. · Model 2530 · UDI-DI 00874750008940

BYX Prescription
10
510(k) clearances
518
Adverse events (14 deaths)
1
Recalls
230
Facilities

Description

2530 INFL-3 BALLOON CNTRL 115V

Recalls

DateFirmReason
2018-08-10A M Systems IncSome of the Disposable Smooth Interior Tubing may pull apart when stretched.

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Data 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.