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Z-MED™

B BRAUN INTERVENTIONAL SYSTEMS, INC · Model 610494 · UDI-DI 04046964329432

OZTLIT Prescription
2
510(k) clearances
367
Adverse events (35 deaths)
2
Recalls
24
Facilities

Description

PDZ344 SPECIAL Z-MED 6X3X100

Recalls

DateFirmReason
2014-03-14InterValve IncLeak issues were discovered through accelerated age testing.
2013-03-18Loma Vista MedicalSlow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specificat

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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.