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Impact™

B BRAUN INTERVENTIONAL SYSTEMS, INC · Model 202120A · UDI-DI 04046964325830

KNQLIT Prescription
10
510(k) clearances
5,224
Adverse events (16 deaths)
21
Recalls
59
Facilities

Description

IMPACT 20MMX2CMX120CM

Recalls

DateFirmReason
2026-03-18Diversatek HealthcareThe catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2026-03-18Diversatek HealthcareThe catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2026-03-18Diversatek HealthcareThe catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2026-03-18Diversatek HealthcareThe catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
2013-05-28Boston Scientific CorporationProduct labeled with incorrect expiration date.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.

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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.