WALLACH Cryosurgical Equipment 900076Recalls & reported problems
Coopersurgical, Inc. · WALLACH Cryosurgical Equipment UltraFreeze Liquid Nitrogen Sprayer (.5 liter) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888937010961), received between Mar 31, 2022 and Aug 24, 2023 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Defective Component” (11 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.
Most reported problems
Device problems
- Defective Component11
- Mechanical Problem3
- Break2
- Fracture1
- Gas/Air Leak1
- Leak/Splash1
- Material Twisted/Bent1
- No Pressure1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2023Mechanical Problem; Mechanical Problem
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610629 ↗MalfunctionAug 24, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610308 ↗MalfunctionAug 23, 2023Gas/Air Leak; Gas/Air Leak
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17606960 ↗MalfunctionAug 9, 2023Mechanical Problem; Mechanical Problem
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17489183 ↗MalfunctionJul 11, 2023Mechanical Problem; Mechanical Problem
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17299007 ↗MalfunctionJul 11, 2023Fracture; Fracture
IT WAS REPORTED THAT THE HANDLE TO RELEASE WAS BROKEN. NO ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. 900076 ULTRA FREEZE 2023-06-0000400.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17299003 ↗MalfunctionApr 10, 2023Defective Component; Defective Component
AS PER DETAILS REPORTED ON (B)(4) FROM FS LOG # (B)(4). CRYOSURGICAL SYSTEM "LEAKING AIRGASS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16709351 ↗MalfunctionApr 10, 2023Defective Component; Defective Component
BOTTLE FREEZES ON THE OUTSIDE, WALLACH ULTRA FREEZE 900076 E-COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16708943 ↗MalfunctionMar 23, 2023Defective Component; Defective Component
SPOUT IS LEAKING WALLACH ULTRA FREEZE 900076 E-COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16599019 ↗MalfunctionMar 3, 2023Defective Component; Defective Component
AS PER DETAILS REPORTED ON E-COMPLAINT-(B)(4) FROM FS LOG # 99887. "THE DEVICE DOES NOT HOLD THE PRESSURE THEREFORE THE SPRAY IS WEAK. THE DEVICE CONTINUES TO SPRAY AFTER PRESSING THE TRIGGER ONCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16478070 ↗MalfunctionMar 1, 2023Defective Component; Defective Component
AS PER DETAILS REPORTED ON E-COMPLAINT (B)(4) FROM FS LOG # (B)(4). "THE UNIT/BOTTLE IS LEAKING." WALLACH ULTRA FREEZE 900076 E-COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16460313 ↗MalfunctionNov 11, 2022Defective Component; Defective Component
FREEZING UP. BOTH PINS LOOK RUSTY. SPARE PIN IS ALSO RUSTY. WALLACH ULTRA FREEZE 900076 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15781408 ↗MalfunctionNov 11, 2022Defective Component; Defective Component
FREEZING UP. BOTH PINS LOOK RUSTY. SPARE PIN IS ALSO RUSTY. FS LOG # (B)(4). WALLACH ULTRA FREEZE 900076 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15779938 ↗MalfunctionOct 24, 2022Break; Defective Component; Break; Defective Component
TRIGGER LEVER GETS STUCK. FS LOG# 99264. 1216677-2022-00285 WALLACH ULTRA FREEZE 900076 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15658554 ↗MalfunctionOct 21, 2022Defective Component; Defective Component
BAD SEALS AND TRIGGER OPERATION. WALLACH ULTRA FREEZE 900076 E-COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15651219 ↗MalfunctionOct 13, 2022Defective Component; Defective Component
THE TRIGGER PRESS STAYS ACTIVE AND THE LIQUID NITROGEN KEEPS SPRAYING. WALLACH ULTRA FREEZE 900076 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15596170 ↗MalfunctionSep 2, 2022Defective Component; Defective Component
FREEZES WITH USE AND SPRAYS NITROGEN UNCONTROLLED. FS LOG # 98991. WALLACH ULTRA FREEZE 900076 E-COMPLAINT-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15349892 ↗MalfunctionMar 31, 2022No Pressure; Leak/Splash; No Pressure; Output Problem
LEAKING, INCONSISTENT TRIGGER, INCONSISTENT SPRAY PATTERN, FROSTING CONFIRMED COMPLAINT: BOTTLE LOST VACUUM. REPLACED BOTTLE ASSEMBLY, CLEANED VALVE REPAIR ORDER 98052 1216677-2022-00099 WALLACH ULTRA FREEZE 900076 E-COMPLAINT-(B)(4).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13964873 ↗
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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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