Dilator, Esophageal
FDA adverse event reports and recall history for dilator, esophageal (product code KNQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,193
- Deaths
- 16
- Injuries
- 451
- Malfunctions
- 4,706
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-04-23Open, ClassifiedLabeling Change Control
Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
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.
- 2026-04-23Open, ClassifiedLabeling Change Control
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
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.
- 2026-04-23Open, ClassifiedLabeling Change Control
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
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.
- 2026-04-23Open, ClassifiedLabeling Change Control
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
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.
- 2013-07-10TerminatedIncorrect or no expiration date
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
Product labeled with incorrect expiration date.
- 2007-06-19TerminatedOther
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- 2007-06-19TerminatedOther
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- 2007-06-19TerminatedOther
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- 2007-06-19TerminatedOther
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 8cm; product code/end item #000344 and #000735 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- 2007-06-19TerminatedOther
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 8cm; product code/end item #000345 and #000736 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
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