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n.a.

Karl Storz GmbH & Co. KG · Model 11577BP · UDI-DI 04048551051764

GBA Prescription
5
510(k) clearances
756
Adverse events (55 deaths)
1
Recalls
37
Facilities

Description

Balloon Catheter, 0.9 mm

Recalls

DateFirmReason
2013-05-31Karl Storz Endoscopy America IncKarl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be

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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.