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Disposable Dilation Balloon

Micro-Tech (Nanjing) Co., Ltd. · Model BDC-15/55-7/10-A · UDI-DI 06932503520522

KNQ Prescription

510(k) clearances

5,224

Adverse events (16 deaths)

Recalls

Facilities

Description

the balloon diameter is 15mm, the balloon length is 55mm, the catheter diameter is 7 Fr., and the working length is 1000mm,with stainless steel guide wire

Recalls

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