Dilator, Esophageal
Gastroenterology, Urology · 21 CFR 876.5365
Recent MDR events
5,224 adverse event reports on file
- CRE Fixed WireJul 31, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03106
- CRE Fixed WireJul 31, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03127
- EZDILATE BALLOON DILATOR (FW) 18-19-20Jul 30, 2026InjuryGyrus Acmi, Inc.3011050570-2026-00770
- EZDILATE BALLOON DILATOR (FW) 18-19-20Jul 27, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00760
- HERCULES 3 STAGE BALLOON ESOPHAGEALJul 27, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00366
- CRE FIXED WIREJul 22, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03000
- CRE FIXED WIREJul 17, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02902
- CRE FIXED WIREJul 17, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02901
- HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONICJul 15, 2026MalfunctionWilson-cook Medical Inc (cook Endoscopy)1037905-2026-00349
- CRE PRO GIJul 15, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02857
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Burst Container or Vessel”
Recalls
21 recall events for this product code
- Diversatek HealthcareOpen, ClassifiedApr 23, 2026
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.
Z-1938-2026 · View FDA record ↗ - Diversatek HealthcareOpen, ClassifiedApr 23, 2026
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.
Z-1939-2026 · View FDA record ↗ - Diversatek HealthcareOpen, ClassifiedApr 23, 2026
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.
Z-1940-2026 · View FDA record ↗ - Diversatek HealthcareOpen, ClassifiedApr 23, 2026
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.
Z-1941-2026 · View FDA record ↗ - Boston Scientific CorporationTerminatedJul 10, 2013
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510
Product labeled with incorrect expiration date.
Z-1671-2013 · View FDA record ↗ - Conmed Endoscopic Technologies, Inc.TerminatedJun 19, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile; dist
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Z-0937-2007 · View FDA record ↗ - Conmed Endoscopic Technologies, Inc.TerminatedJun 19, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile; dis
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Z-0938-2007 · View FDA record ↗ - Conmed Endoscopic Technologies, Inc.TerminatedJun 19, 2007
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
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Z-0939-2007 · View FDA record ↗ - Conmed Endoscopic Technologies, Inc.TerminatedJun 19, 2007
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
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Z-0940-2007 · View FDA record ↗ - Conmed Endoscopic Technologies, Inc.TerminatedJun 19, 2007
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
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Z-0941-2007 · View FDA record ↗
Registered firms
83 firms currently registered for this product code
Cbr Enterprise Limited
Hong Kong, HK
Merit Medical Uk Limited
Earley Reading, GB
Conmed Corporation
Utica, NY, US
Changzhou Health Microport Medical Device Co.,ltd.
Changzhou Jiangsu, CN
Cordis Us Corp.
Miami Lakes, FL, US
Quasar Medical Tecate, S.a. De C.v
Tecate Baja California, MX
Boston Scientific Limited
CORK Munster, IE
Micro-tech (nanjing) Co., Ltd.
Nanjing Jiangsu, CN
Terumo Bct Sterilization Services, Inc.
LAKEWOOD, CO, US
Cook Incorporated
Bloomington, IN, US
Boston Scientific Corporation
Marlborough, MA, US
Lynx Medical Pennsylvania
ERIE, PA, US
Synergy Health Ast, Srl
Alajuela, CR
Merit Medical Systems, Inc.
South Jordan, UT, US
Diversatek Healthcare Inc
Milwaukee, WI, US
Nitinol Devices & Components Costa Rica, S. R. L.
El Coyol Alajuela, CR
Ovesco Endoscopy Usa
Cary, NC, US
Consolidated Medical Equipment Company
Chihuahua, MX
Voma Ecza Deposu Medikal Urunler San. Tic. A.s.
IZMIR, TR
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Isomedix Operations Inc.
Northborough, MA, US
Conmed Corporation
WESTBOROUGH, MA, US
Biorad Medisys Pvt. Ltd.
Pune Maharashtra, IN
510(k) clearances
40 clearances for this product code
- Boston Scientific CorpOct 24, 2012
K122924 · CRE FIXED WIRE BALLON DILATION CATHETER
- Ethicon Endo-Surgery, Inc.Nov 10, 2009
K093236 · ETHICON ENDO-SURGERYOPTICAL DILATOR
- Cook EndoscopySep 25, 2009
K090183 · HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
- Safestitch MedicalFeb 6, 2009
K082995 · SMART DILATOR
- Cook EndoscopyDec 1, 2006
K061937 · COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
- Boston Scientific CorpSep 21, 2006
K061787 · MAXFORCE TTS SINGLE-USE BALLOON DILATOR
- Cordis Europa, N.V.Apr 11, 2006
K060302 · INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
- Cordis Europa, N.V.Feb 4, 2005
K043605 · INSCOPE 3-STAGE BALLOON DILATOR