Spray Catheter WP-18/2200Recalls & reported problems
Micro-Tech (Nanjing) Co., Ltd. · Blue handle 1.8mm OD 2200mm length · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 06932503562249), received between Dec 31, 2024 and Apr 23, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Crack” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack2
- Obstruction of Flow2
- Defective Device1
- Deformation Due to Compressive Stress1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Difficult to Remove
IT WAS REPORTED BY THE HOSPITAL STAFF THAT THE PRODUCT WAS UNABLE TO EXPEL FROM CATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24963329 ↗MalfunctionApr 16, 2026
FROM STAFF: UNABLE TO EXPEL FROM CATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895066 ↗MalfunctionMar 20, 2026Deformation Due to Compressive Stress
IT WAS REPORTED THAT KINK IN CATHETER PRIOR TO OPENING; UNABLE TO PUSH PRODUCT PROPERLY AND CAUSES LEAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646892 ↗MalfunctionMar 4, 2026
FROM STAFF: KINK IN CATHETER PRIOR TO OPENING; UNABLE TO PUSH PRODUCT PROPERLY AND CAUSES LEAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505660 ↗MalfunctionAug 26, 2025Obstruction of Flow; Obstruction of Flow
FROM STAFF: DURING AN EGD [ESOPHAGOGASTRODUODENOSCOPY] NEEDED TO USE PURASTAT TO STOP BLEEDING AND THE SPRAY CATHETER WOULD NOT PUSH THE MEDICATION THROUGH. SPRAY CATHETER REF#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22892517 ↗MalfunctionJul 15, 2025Obstruction of Flow; Defective Device
FROM STAFF: DURING AN EGD [ESOPHAGOGASTRODUODENOSCOPY] NEEDED TO USE PURASTAT TO STOP BLEEDING AND THE SPRAY CATHETER WOULD NOT PUSH THE MEDICATION THROUGH. SPRAY CATHETER REF# WP-18/2200.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22506476 ↗MalfunctionJan 17, 2025Crack; Crack
ON 12/30/2024, MICRO-TECH RECEIVED 1 INCIDENT REPORT REGARDING SPRAY CATHETER FROM FDA. UF REPORT#: (B)(4). THIS IS THE SECOND REPORT FOR ANOTHER DEVICE USED IN OTHER DIFFERENT PATIENT. OUR FIRST REPORT REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT -D MATRIX PURASTAT SPRAY CATHETER LOT#: M230925311 REF#: WP-18/2200, ADAPTER APPLIED TO PURASTAT GEL SYRINGE AND SPRAY CATHETER AND PURASTAT GEL INJECTED INTO CATHETER SYRINGE THEN DISCONNECTED AND FILLED WITH AIR AS IFU INSTRUCTS. AFTER SYRINGE APPLIED BACK ONTO SPRAY CATHETER TO DELIVER THE GEL FROM THE CATHETER IT WAS FOUND TO HAVE NO GEL EXPELLING CATHETER. UPON FURTHER EXAMINATION IT APPEARED THAT BLUE CONNECTION PORT ON SPRAY CATHETER WAS CRACKED WHICH KEPT THE PRODUCT FROM DISPENSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21176849 ↗MalfunctionDec 31, 2024Crack; Crack
ON 12/30/2024, MICRO-TECH RECEIVED 1 INCIDENT REPORT REGARDING SPRAY CATHETER FROM FDA. UF REPORT#: (B)(4). IT WAS REPORTED THAT -D MATRIX PURASTAT SPRAY CATHETER LOT# M230925311 REF#(B)(4) ADAPTER APPLIED TO PURASTAT GEL SYRINGE AND SPRAY CATHETER AND PURASTAT GEL INJECTED INTO CATHETER SYRINGE THEN DISCONNECTED AND FILLED WITH AIR AS IFU INSTRUCTS. AFTER SYRINGE APPLIED BACK ONTO SPRAY CATHETER TO DELIVER THE GEL FROM THE CATHETER IT WAS FOUND TO HAVE NO GEL EXPELLING CATHETER. UPON FURTHER EXAMINATION IT APPEARED THAT BLUE CONNECTION PORT ON SPRAY CATHETER WAS CRACKED WHICH KEPT THE PRODUCT FROM DISPENSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046059 ↗
Other Adaptor, Catheter devices
- Cardiothoracic Adaptor 072510C. R. Bard, Inc. · ADAPTOR, CATHETER4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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